Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-28 @ 9:10 PM
Study NCT ID:
NCT01847105
Status:
UNKNOWN
Last Update Posted:
2013-05-29
First Post:
2013-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-25', 'studyFirstSubmitDate': '2013-04-24', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported comfort scores with contact lens care systems', 'timeFrame': '14 days', 'description': 'Comfort measured by questionnaires covering positive and negative attributes of contact lens wear'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contact Lens Solution Toxicity']}, 'descriptionModule': {'briefSummary': 'Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).', 'detailedDescription': "According to recent surveys of contact lens fitters, the most prescribed treatments for contact lens dryness are: more frequent replacement schedule (24%), refit into different material (23%), rewetting drops (21%) and change care system (15%). Changing care systems has been a standard treatment for CL discomfort for many years. In the same survey, 30% of practitioners felt there is absolutely no difference among solutions with respect to reducing dryness and discomfort.\n\nThe investigators set out to compare the clinical performance of these two solutions: AMO's RevitaLens and Alcon's Opti-Free PureMoist."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between the ages of 18 and over inclusive.\n2. Males or females\n3. Patient is in generally good \\& stable overall health.\n4. Patient likely to comply with study guidelines \\& study visits.\n5. Informed consent signed.\n6. Are willing/able to return for all required study visits.\n7. Are willing/able to follow instructions from the study investigator and his/her staff.\n8. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.\n\nExclusion Criteria:\n\n1. Corneal refractive surgery within 6 months of this study.\n2. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.\n3. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.'}, 'identificationModule': {'nctId': 'NCT01847105', 'briefTitle': 'Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions', 'organization': {'class': 'INDIV', 'fullName': 'Hom, Milton M., OD, FAAO'}, 'officialTitle': 'Assessing Patient Comfort in Silicone Hydrogel Contact Lenses When Cleaned and Stored in Two Different Multi-Purpose Disinfecting Solutions', 'orgStudyIdInfo': {'id': '12-GHS Comfort Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RevitaLens', 'description': "AMO's RevitaLens contact lens solution", 'interventionNames': ['Other: RevitaLens', 'Other: OptiFree PureMoist']}], 'interventions': [{'name': 'RevitaLens', 'type': 'OTHER', 'otherNames': ["AMO's RevitaLens"], 'description': 'Multi-purpose disinfecting solution', 'armGroupLabels': ['RevitaLens']}, {'name': 'OptiFree PureMoist', 'type': 'OTHER', 'otherNames': ["Alcon's OptiFree PureMoist MPS"], 'description': 'Multi-purpose disinfecting solution', 'armGroupLabels': ['RevitaLens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'Milton M. Hom, OD, FAAO', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}, {'zip': '30260', 'city': 'Morrow', 'state': 'Georgia', 'country': 'United States', 'facility': 'Kirk L. Smick, OD, FAAO.', 'geoPoint': {'lat': 33.58317, 'lon': -84.33937}}, {'zip': '40222', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Ian Ben Gaddie, OD, FAAO.', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Milton M Hom, OD FAAO', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hom, Milton M., OD, FAAO', 'class': 'INDIV'}, 'collaborators': [{'name': 'Abbott Medical Optics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Optometrist', 'investigatorFullName': 'Milton M. Hom, OD, FAAO.', 'investigatorAffiliation': 'Hom, Milton M., OD, FAAO'}}}}