Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-04-11 @ 10:10 PM
Study NCT ID:
NCT02196766
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2014-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540498', 'term': 'comfilcon A'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'taku.muraoka@jp.coopervision.com', 'phone': '81-3-5449-6619', 'title': 'Taku Muraoka, OD, Director Professional Services Organization', 'organization': 'Coopervision Japan'}, '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': {'timeFrame': 'From dispense up to two weeks for study lenses with both study lens care solutions', 'eventGroups': [{'id': 'EG000', 'title': 'Bioclean First Care EX / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nBioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aosept Clearcare / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nBioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Health - Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bioclean First Care EX / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nBioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}, {'id': 'OG001', 'title': 'Aosept Clearcare / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nAosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Stinging Sensation Right After Insertion (Subjective Rating)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bioclean First Care EX / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nBioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}, {'id': 'OG001', 'title': 'Aosept Clearcare / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nAosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Burning Sensation Right After Insertion (Subjective Rating)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bioclean First Care EX / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nBioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}, {'id': 'OG001', 'title': 'Aosept Clearcare / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nAosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ocular Health - Conjunctival Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bioclean First Care EX / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nBioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}, {'id': 'OG001', 'title': 'Aosept Clearcare / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nAosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Ocular Health - Limbal Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bioclean First Care EX / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nBioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}, {'id': 'OG001', 'title': 'Aosept Clearcare / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nAosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'PRIMARY', 'title': 'Ocular Health - Papillary Conjunctivitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bioclean First Care EX / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nBioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}, {'id': 'OG001', 'title': 'Aosept Clearcare / Comfilcon A', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.\n\nAosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Trace', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bioclean First Care EX Combo, Then Aosept Clearcare Combo', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}, {'id': 'FG001', 'title': 'Aosept Clearcare Combo First,Then Bioclean First Care EX Combo', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}], 'periods': [{'title': 'First Intervention (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bioclean First Care EX / Aosept Clearcare / Comfil', 'description': 'Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '7.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Overall participants group prior to randomization of study lens pairs and solution.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2014-07-18', 'resultsFirstSubmitDate': '2015-12-15', 'studyFirstSubmitQcDate': '2014-07-18', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-30', 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Health - Corneal Staining', 'timeFrame': '1 week', 'description': 'Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).'}, {'measure': 'Ocular Health - Conjunctival Redness', 'timeFrame': '1 week', 'description': 'Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).'}, {'measure': 'Ocular Health - Limbal Redness', 'timeFrame': '1 week', 'description': 'Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).'}, {'measure': 'Ocular Health - Papillary Conjunctivitis', 'timeFrame': '1 week', 'description': 'Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).'}], 'secondaryOutcomes': [{'measure': 'Stinging Sensation Right After Insertion (Subjective Rating)', 'timeFrame': 'Baseline', 'description': 'Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).'}, {'measure': 'Burning Sensation Right After Insertion (Subjective Rating)', 'timeFrame': 'Baseline', 'description': 'Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'To determine if patients are unreactive to the lens care solution / Biofinity combination.', 'detailedDescription': 'To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is over 18 years of age (inclusive)\n* Has had a self-reported visual exam in the last two years\n* Is currently an adapted spherical soft CL wearer\n* Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)\n* Has less than 1.00D spectacle cylinder in each eye.\n* Is correctable to a visual acuity of 20/20 or better in both eyes\n* Has clear corneas and no active ocular disease\n* Has read, understood and signed the information consent letter.\n* Is willing to comply with the wear schedule (at least 40 hrs per week)\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 - 0.25 to -12.00D\n* Has a spectacle cylinder greater than -0.75D of cylinder in either eye.\n* Has best corrected spectacle distance vision worse than 20/20 in either eye.\n* Has any systemic disease affecting ocular health.\n* Is using any systemic or topical medications that will affect ocular health.\n* Has any ocular pathology or severe insufficiency of lacrimal secretion\n* Has persistent, clinically significant corneal or conjunctival staining\n* Has active neovascularization or any central corneal scars.\n* Is aphakic.\n* Is pregnant or lactating.\n* Has undergone corneal refractive surgery.\n* Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT02196766', 'briefTitle': 'BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study', 'orgStudyIdInfo': {'id': 'CVJ-EX-MKTG-1818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bioclean First Care EX combo, then Aosept Clearcare combo', 'description': 'Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination.', 'interventionNames': ['Other: Bioclean First Care EX / comfilcon A', 'Other: Aosept Clearcare / comfilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aosept Clearcare combo, then Bioclean First Care EX combo', 'description': 'Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination.', 'interventionNames': ['Other: Bioclean First Care EX / comfilcon A', 'Other: Aosept Clearcare / comfilcon A']}], 'interventions': [{'name': 'Bioclean First Care EX / comfilcon A', 'type': 'OTHER', 'description': 'Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.', 'armGroupLabels': ['Aosept Clearcare combo, then Bioclean First Care EX combo', 'Bioclean First Care EX combo, then Aosept Clearcare combo']}, {'name': 'Aosept Clearcare / comfilcon A', 'type': 'OTHER', 'description': 'Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.', 'armGroupLabels': ['Aosept Clearcare combo, then Bioclean First Care EX combo', 'Bioclean First Care EX combo, then Aosept Clearcare combo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610-0121', 'city': 'Joyo-shi', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Kokama Eye Clinic'}, {'zip': '621-0861', 'city': 'Kameoka', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Higashihara Clinic', 'geoPoint': {'lat': 35.0, 'lon': 135.58333}}, {'zip': '150-0043', 'city': 'Shibuya-ku', 'state': 'Tokyo-to', 'country': 'Japan', 'facility': 'Dougenzaka Ioti Eye Clinic'}], 'overallOfficials': [{'name': 'Taku Muraoka, OD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director Professional Services, CVI Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}