Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT00382603
Status:
COMPLETED
Last Update Posted:
2012-08-16
First Post:
2006-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-15', 'studyFirstSubmitDate': '2006-09-28', 'studyFirstSubmitQcDate': '2006-09-28', 'lastUpdatePostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy:'}, {'measure': 'Ocular Comfort and Symptom Scales'}, {'measure': 'Subject Questions/Subject Likert Questionnaire'}, {'measure': 'Safety:'}, {'measure': 'Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications'}, {'measure': 'Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Corneal Fluorescein Staining (Type and Area)'}, {'measure': 'Lens Surface Evaluation (Lens Deposit and Lens Wettability)'}, {'measure': 'Lens Replacement Incidence and Causality'}, {'measure': 'Corrected Visual Acuity with Study Lenses (Snellen)'}, {'measure': 'Rewetting Drop Frequency'}, {'measure': 'Lens Removal Frequency'}, {'measure': 'Average Lens Wearing Time'}, {'measure': 'Average Uncomfortable Lens Wearing Time'}]}, 'conditionsModule': {'keywords': ['Contact Lens Care'], 'conditions': ['Contact Lens Care']}, 'descriptionModule': {'briefSummary': 'The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic for contact lens related discomfort at the end of the lens wearing day.\n* Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.\n* Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).\n* Successful lens wear for at least 4 hours per day.\n* Vision correctable to 20/30.\n* Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.\n* No corneal surgery within the past 12 months.\n* No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.\n* No over-the-counter or prescription ocular medication.\n* No enrollment in another clinical study within 30 days prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT00382603', 'briefTitle': 'Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses in Symptomatic Patients', 'orgStudyIdInfo': {'id': 'C-04-09'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OptiFree Multi-Purpose Disinfecting Solution', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80126', 'city': 'Highlands Ranch', 'state': 'Colorado', 'country': 'United States', 'facility': 'Highlands Ranch', 'geoPoint': {'lat': 39.55388, 'lon': -104.96943}}], 'overallOfficials': [{'name': 'Leslie Napier', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}