Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT02131402
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2014-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.montes@uv.es', 'phone': '34-9635-44764', 'title': 'Dr. Robert Montés-Mico O.D., MPhil, PhD', 'organization': 'Optics Department, University of Valencia 46100 Valencia, Spain'}, 'certainAgreement': {'otherDetails': "Principal Investigators are NOT employed by the organization sponsoring the study.\n\nThere IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.\n\nThe investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Enfilcon A / Omafilcon A', 'description': 'Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.\n\nomafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye.', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enfilcon A / Ocufilcon D', 'description': 'Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.\n\nocufilcon D: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye.', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Enfilcon A / Methafilcon A', 'description': 'Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.\n\nmethafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '84', 'spread': '20.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Wearing Ocufilcon D in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '90', 'spread': '13.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (1 hour). Rated by questionnaires (0=Very difficult 0-100, 100= very easy).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Wearing Methafilcon A in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '86', 'spread': '17.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3. Rated by questionnaires (0-100 0=Very difficult, 100= very easy).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Wearing Enfilcon A in one eye. Surveyed after insertion of each lens Pair #2 (at insertion).'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Wearing Ocufilcon D in the contra lateral eye. Surveyed after insertion of each lens Pair #2 (at insertion).'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '82', 'spread': '18.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Surveyed after insertion of each lens Pair #2 (at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants surveyed at baseline, wearing Enfilcon A in one eye'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Participants surveyed at baseline, wearing Omafilcon A in the contra lateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '73', 'spread': '17.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Wearing Enfilcon A in one eye. Participants surveyed at insertion.'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Wearing Methafilcon A in the contra lateral eye. Participants surveyed at insertion.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '76', 'spread': '18.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '76', 'spread': '16.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': "Surveyed after 1 hour post settling for Pair #1. Rated by questionnaires (0-100, 0= Can't be worn and causes pain, 100= can't feel).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling for Pair #2'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Wearing Ocufilcon D in the contra lateral eye. Surveyed after 1 hour post settling for Pair #2.'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '83', 'spread': '18.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': "Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Participants surveyed after 1 post settling hour, wearing Methafilcon A in the contra lateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '78', 'spread': '17.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hours post settling', 'description': "Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0=Can't be worn and causes pain 100= can't feel).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Subject after insertion of Pair #1 at baseline wearing Enfilcon A in one eye'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Subject after insertion of Pair #1 at baseline wearing Omafilcon A in the contralateral eye.'}], 'classes': [{'title': 'Strong Enfilcon A', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Enfilcon A', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Omafilcon A', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'Strong Omafilcon A', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Wearing Enfilcon A in one eye. Surveyed at insertion of each lens Pair #2.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Wearing Ocufilcon D in the contralateral eye. Surveyed at insertion of each lens Pair #2.'}], 'classes': [{'title': 'Strong Enfilcon A', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Enfilcon A', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Ocufilcon D', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Strong Ocufilcon D', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Surveyed at insertion of each lens Pair #2 by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Subject surveyed after insertion of each lens for Pair #3 wearing Enfilcon A in one eye'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Subject surveyed after insertion of each lens for Pair #3 wearing Methafilcon A in the contralateral eye.'}], 'classes': [{'title': 'Strong Enfilcon A', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Enfilcon A', 'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Methafilcon A', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Strong Methfilcon A', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Surveyed after insertion of each lens for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye'}], 'classes': [{'title': 'Strong Enfilcon A', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Enfilcon A', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No preference', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Omafilcon A', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Strong Omafilcon A', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Wearing Ocufilcon D in contralateral eye. Surveyed after 1 hour post settling.'}], 'classes': [{'title': 'Strong Enfilcon A', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Enfilcon A', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Ocufilcon D', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Strong Ocufilcon D', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour post settling for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Wearing Enfilcon A in one eye, surveyed at 1 hour post settling.'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Wearing Methafilcon A in the contralateral eye, surveyed at 1 hour post settling.'}], 'classes': [{'title': 'Strong Enfilcon A', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Enfilcon A', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slight Methafilcon A', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Strong Methafilcon A', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour post settling for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Assessed after 1 hour post settling. Post-blink movement, wearing Omafilcon A in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Assessed after 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Assessed at 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Assessed at 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Assessed after 1 hour post settling. Push up test, wearing Omafilcon A in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '50', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Assessed after 1 hour post settling. Push up test, wearing Ocufilcon D in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '50', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Assessed at 1 hour post settling. Push up test, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Assessed at 1 hour post settling. Push up test, wearing Methafilcon A in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '50', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #3. (Scale 0%-100%, 0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Assessed after 1 hour post settling wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Assessed after 1 hour post settling, wearing Omafilcon A in contralateral eye'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Decentration acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decentration unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable).', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Assessed after 1 hour post settling, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Assessed after 1 hour post settling, wearing Ocufilcon D in contralateral eye.'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Decentration Acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decentration Unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Assessed at 1 hour post settling, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Assessed at 1 hour post settling, wearing Methafilcon A in contralateral eye.'}], 'classes': [{'title': 'Optimum', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Decentration acceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decentration unacceptable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants surveyed at baseline, wearing Enfilcon A in one eye'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Participants surveyed at baseline, wearing Omafilcon A in contralateral eye'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '18', 'spread': '22.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Surveyed after insertion of each lens for Pair #1 at baseline visit. Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Surveyed after insertion at baseline, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Surveyed after insertion at baseline, wearing Ocufilcon D in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '11', 'spread': '20.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants surveyed at baseline, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Participants surveyed at baseline, wearing Methafilcon A in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '15', 'spread': '19.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants surveyed after 1 hour wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Participants surveyed after1 hour wearing Omafilcon A in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Participants surveyed at 1 hour post settling, wearing Ocufilcon D in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '13.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Participants surveyed at 1 hour post settling, wearing Methafilcon A in contralateral eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '13', 'spread': '18.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.'}, {'id': 'OG001', 'title': 'Omafilcon A', 'description': 'Participants vision tested both eyes wearing omafilcon A, prior to dispensing contralateral pairs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.041', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.035', 'spread': '0.055', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.'}, {'id': 'OG001', 'title': 'Ocufilcon D', 'description': 'Participants vision tested both eyes wearing ocufilcon D, prior to dispensing contralateral pairs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.041', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.040', 'spread': '0.049', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfilcon A', 'description': 'Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.'}, {'id': 'OG001', 'title': 'Methafilcon A', 'description': 'Participants vision tested both eyes wearing Methafilcon A, prior to dispensing contralateral pairs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.041', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.043', 'spread': '0.050', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post settling', 'description': 'Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Participants Flow', 'description': 'Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.\n\nomafilcon A/ocufilcon D/methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A)/(ocufilcon D)/(methafilcon A)in the contra lateral eye.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There were 60 subjects enrolled and fitted with the study lenses. All sixty subjects completed the trial (i.e. no discontinuations).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enfilcon A / Omafilcon A/Ocufilcon D/Methafilcon A', 'description': 'Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.\n\nContralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contralateral eye. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.78', 'spread': '5.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2014-04-28', 'resultsFirstSubmitDate': '2016-02-22', 'studyFirstSubmitQcDate': '2014-05-02', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-10', 'studyFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).'}, {'measure': "Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D", 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (1 hour). Rated by questionnaires (0=Very difficult 0-100, 100= very easy).'}, {'measure': "Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3. Rated by questionnaires (0-100 0=Very difficult, 100= very easy).'}, {'measure': 'Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D', 'timeFrame': 'Baseline', 'description': "Surveyed after insertion of each lens Pair #2 (at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel)."}, {'measure': "Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A", 'timeFrame': 'Baseline', 'description': "Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel)."}, {'measure': "Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A", 'timeFrame': 'Baseline', 'description': "Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel)."}, {'measure': "Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A", 'timeFrame': '1 hour post settling', 'description': "Surveyed after 1 hour post settling for Pair #1. Rated by questionnaires (0-100, 0= Can't be worn and causes pain, 100= can't feel)."}, {'measure': "Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D", 'timeFrame': '1 hour post settling', 'description': "Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel)."}, {'measure': "Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A", 'timeFrame': '1 hours post settling', 'description': "Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0=Can't be worn and causes pain 100= can't feel)."}, {'measure': 'Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A', 'timeFrame': 'Baseline', 'description': 'Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).'}, {'measure': 'Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D', 'timeFrame': 'Baseline', 'description': 'Surveyed at insertion of each lens Pair #2 by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).'}, {'measure': 'Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A', 'timeFrame': 'Baseline', 'description': 'Surveyed after insertion of each lens for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).'}, {'measure': "Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).'}, {'measure': "Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D", 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour post settling for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).'}, {'measure': "Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour post settling for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).'}, {'measure': "Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)'}, {'measure': "Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D", 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)'}, {'measure': "Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)'}, {'measure': "Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).'}, {'measure': "Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D", 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).'}, {'measure': "Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #3. (Scale 0%-100%, 0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)'}, {'measure': "Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable).'}, {'measure': "Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D", 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)'}, {'measure': "Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)'}, {'measure': "Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A", 'timeFrame': 'Baseline', 'description': 'Surveyed after insertion of each lens for Pair #1 at baseline visit. Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging).'}, {'measure': 'Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D', 'timeFrame': 'Baseline', 'description': 'Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)'}, {'measure': 'Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A', 'timeFrame': 'Baseline', 'description': 'Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging).'}, {'measure': 'Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A', 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging).'}, {'measure': "Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D", 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).'}, {'measure': "Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).'}, {'measure': "Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)'}, {'measure': "Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D", 'timeFrame': '1 hour post settling', 'description': 'Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)'}, {'measure': "Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A", 'timeFrame': '1 hour post settling', 'description': 'Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens handling, lens fitting characteristics and visual acuity of different hydrogel lens designs versus silicone hydrogel lenses', 'detailedDescription': 'This is a 60-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different lens materials (hydrogel vs silicone hydrogel). It is anticipated that this study will involve 2 visits, for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear the test and control lenses in a series of three short fitting comparisons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is between 18 and 40 years of age (inclusive)\n* Has had a self-reported visual exam in the last two years\n* Is an adapted soft CL (Contact Lens) wearer\n* Has a CL spherical prescription between - 1.00 and - 10.00 (inclusive)\n* Has a spectacle cylinder up to 0.75D (Diopter) in each eye.\n* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.\n* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.\n* Has clear corneas and no active ocular disease\n* Has read, understood and signed the information consent letter\n* Patient contact lens refraction should fit within the available parameters of the study lenses\n* Is willing to comply with the wear schedule\n* Is willing to comply with the visit schedule\n\nExclusion Criteria:\n\n* Has never worn contact lenses before.\n* Currently wears rigid gas permeable contact lenses.\n* Has a history of not achieving comfortable CL wear (5 days per week; \\> 8 hours/day)\n* Has a CL prescription outside the range of - 1.00 to -10.00D\n* Has a spectacle cylinder ≥1.00D of cylinder in either eye.\n* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.\n* Presence of clinically significant (grade 2-4) anterior segment abnormalities.\n* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.\n* Slit lamp findings that would contraindicate contact lens wear such as:\n\n * Pathological dry eye or associated findings\n * Pterygium, pinguecula, or corneal scars within the visual axis\n * Neovascularization \\> 0.75 mm in from of the limbus\n * Giant papillary conjunctivitis (GCP) worse than grade 1\n * Anterior uveitis or iritis (past or present)\n * Seborrheic eczema, Seborrheic conjunctivitis\n * History of corneal ulcers or fungal infections\n * Poor personal hygiene\n* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)\n* Has aphakia, keratoconus or a highly irregular cornea.\n* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.\n* Has undergone corneal refractive surgery.\n* Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT02131402', 'briefTitle': 'Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Non-Dispensing Fitting Study Comparing the Clinical Performance of Hydrogel vs. Silicone Hydrogel Sphere Design Contact Lenses', 'orgStudyIdInfo': {'id': 'EX-MKTG-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'enfilcon A / omafilcon A', 'description': 'Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.', 'interventionNames': ['Device: omafilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'enfilcon A / ocufilcon D', 'description': 'Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.', 'interventionNames': ['Device: ocufilcon D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'enfilcon A / methafilcon A', 'description': 'Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.', 'interventionNames': ['Device: methafilcon A']}], 'interventions': [{'name': 'ocufilcon D', 'type': 'DEVICE', 'otherNames': ['Hydrogel Contact Lens'], 'description': 'Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye.', 'armGroupLabels': ['enfilcon A / ocufilcon D']}, {'name': 'omafilcon A', 'type': 'DEVICE', 'otherNames': ['Hydrogel Contact Lens'], 'description': 'Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye.', 'armGroupLabels': ['enfilcon A / omafilcon A']}, {'name': 'methafilcon A', 'type': 'DEVICE', 'otherNames': ['Hydrogel Contact Lens'], 'description': 'Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.', 'armGroupLabels': ['enfilcon A / methafilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46100', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Optometry Research Group (GIO) Optics Department, University of Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Robert Montés-Mico, OD MPhil PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optics Department, University of Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}