Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 10:56 PM
Study NCT ID:
NCT01061268
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2010-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Evaluation Pilot Study of the Efficacy of Blink® Tears Lubricant Eye Drops for the Relief of Dry Eye Symptoms Following Implantation of Tecnis® Multifocal Introcular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-15', 'studyFirstSubmitDate': '2010-02-01', 'studyFirstSubmitQcDate': '2010-02-02', 'lastUpdatePostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and efficacy of BLINK™ tears', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relief of dry eye symptoms following implantation of TMF IOL'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': "To evaluate the safety and efficacy of BLINK™ tears compared with NO topical artificial tear use in improving subject's visual performance and reduce ocular symptoms of discomfort in subjects who have undergone cataract surgery implanted with a Tecnis™ diffractive multifocal intraocular lens (IOL)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects, 21 years of age or older\n* Written, informed consent and HIPPA Authorization\n* Has 20/40 or better best corrected visual acuity in the surgical eye at the Day 1 post-op visit (Visit 3)\n* Has undergone cataract surgery in only one eye and has received a Tecnis multi-focal intraocular lens in the study eye.\n* Patients not currently using any artificial tears regularly, or using low viscosity tears for symptom relief (Refresh Tears, Visine Tears, Tears Naturelle, etc.)\n* Likely to complete the entire course of the study.\n\nExclusion Criteria:\n\n* Use of systemic or ocular medications that may affect vision\n* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)\n* Subjects with diabetes mellitus\n* Uncontrolled systemic or ocular disease\n* History of ocular trauma or prior ocular surgery\n* Amblyopia or strabismus\n* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)\n* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse\n* Subjects who may be expected to require retinal laser treatment or other surgical intervention\n* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)\n* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)\n* Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses\n* A subject whose best-corrected visual acuity is worse than 20/40 in their surgical eye\n* A subject with any UNCONTROLLED systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study\n* A subject that required the use of any artificial tear supplements, vasoconstrictor and/or redness reliever ocular drops 28 days prior to or during the study period\n* A subject that required the use of cyclosporine ocular drops 3 months prior to or during the study period\n* A subject with active ocular inflammation or corneal edema beyond what is expected on Day 1 after cataract surgery in the study eye\n* A subject with a history of conjunctivitis or ocular infection in the study eye within the past 3 months, or a history of kerato-refractive surgery in the study eye within the past 6 months of entry in to the study\n* A subject that has punctual plug(s), intracanalicular plug(s) or a history of punctual cautery in the study eye'}, 'identificationModule': {'nctId': 'NCT01061268', 'briefTitle': 'A Clinical Evaluation Pilot Study of the Efficacy of Blink® Tears Lubricant Eye Drops for the Relief of Dry Eye Symptoms Following Implantation of Tecnis® Multifocal Introcular Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Medical'}, 'officialTitle': 'A Randomized Clinical Evaluation Pilot Study of the Efficacy of Blink® Tears Lubricant Eye Drops for the Relief of Dry Eye Symptoms Following Implantation of Tecnis® Multifocal Introcular Lens', 'orgStudyIdInfo': {'id': 'TMF-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BLINK™ tears', 'interventionNames': ['Drug: Blink® Tears Lubricant Eye Drops']}, {'type': 'NO_INTERVENTION', 'label': 'No topical artificial tear', 'interventionNames': ['Drug: No topical artificial tear']}], 'interventions': [{'name': 'No topical artificial tear', 'type': 'DRUG', 'description': '40 patients randomized to not using a topical artificial tear.', 'armGroupLabels': ['No topical artificial tear']}, {'name': 'Blink® Tears Lubricant Eye Drops', 'type': 'DRUG', 'description': 'Blink® Tears Lubricant Eye Drops', 'armGroupLabels': ['BLINK™ tears']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Schwartz Laser Eye Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Marc Bloomenstein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schwartz Laser Eye Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}