Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-31 @ 8:51 AM
Study NCT ID:
NCT01543061
Status:
COMPLETED
Last Update Posted:
2013-09-27
First Post:
2012-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-26', 'studyFirstSubmitDate': '2012-02-22', 'studyFirstSubmitQcDate': '2012-02-27', 'lastUpdatePostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear Break up Time', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Conjunctival staining measurement', 'timeFrame': '30 days'}, {'measure': 'Tear film evaporation rate', 'timeFrame': '30 days'}, {'measure': 'Ocular Surface Disease Index questionnaire', 'timeFrame': '30 days'}, {'measure': 'Comfort, vision and ocular symptoms questionnaire', 'timeFrame': '30 days'}, {'measure': 'Post wear contact lens deposition and lipid uptake assessment', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contact Lens Related Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Current silicone hydrogel contact lens wearer\n* Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)\n\nExclusion criteria:\n\n* Known allergy or sensitivity to the study product(s) or its components\n* Systemic or ocular allergies\n* Use of systemic medication which might have ocular side effects.\n* Any ocular infection.\n* Use of ocular medication.\n* Significant ocular tissue anomaly'}, 'identificationModule': {'nctId': 'NCT01543061', 'briefTitle': 'Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints', 'organization': {'class': 'OTHER', 'fullName': 'Optometric Technology Group Ltd'}, 'officialTitle': 'Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints', 'orgStudyIdInfo': {'id': 'AG9965-006 ID 11-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'New study eye drop', 'description': 'One month of contact lens wear with use of the Test study eye drops', 'interventionNames': ['Device: OPTIVEtm Plus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Eyedrop', 'description': 'One month of contact lens wear with no eye drop use', 'interventionNames': ['Procedure: No treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BLINK Contacts Lubricating eye drop', 'description': 'One month of contact lens wear with use of the Control study eye drops', 'interventionNames': ['Device: Blink Contacts® Eye Drops']}], 'interventions': [{'name': 'OPTIVEtm Plus', 'type': 'DEVICE', 'description': '1 drop in each eye four times a day for a period of 30 (± 3) days', 'armGroupLabels': ['New study eye drop']}, {'name': 'No treatment', 'type': 'PROCEDURE', 'description': 'One month of contact lens wear with no eye drop use', 'armGroupLabels': ['No Eyedrop']}, {'name': 'Blink Contacts® Eye Drops', 'type': 'DEVICE', 'otherNames': ['Blink Contacts®'], 'description': '1 drop in each eye four times a day for a period of 30 (± 3) days', 'armGroupLabels': ['BLINK Contacts Lubricating eye drop']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW1E 6AU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'OTG Research & Consultancy', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Michel Guillon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optometric Technology Group Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optometric Technology Group Ltd', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}