Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT00833235
Status:
COMPLETED
Last Update Posted:
2017-07-25
First Post:
2009-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Natural History Study of Patients With Dry Eye
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065346', 'term': 'Lubricant Eye Drops'}], 'ancestors': [{'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D054327', 'term': 'Lubricants'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tear collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-22', 'studyFirstSubmitDate': '2009-01-30', 'studyFirstSubmitQcDate': '2009-01-30', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients with Progression of Dry Eye Disease', 'timeFrame': 'Baseline, 60 Months'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score', 'timeFrame': 'Baseline, 60 Months'}, {'measure': 'Percentage of Patients with an Increase in Blurred Vision', 'timeFrame': 'Baseline, 60 Months'}, {'measure': "Change from Baseline in Schirmer's Test", 'timeFrame': 'Baseline, 60 Months'}, {'measure': 'Change from Baseline in Conjunctival Staining Score on a 6-Point Scale', 'timeFrame': 'Baseline, 60 Months'}, {'measure': 'Change from Baseline in Corneal Staining Score on a 6-Point Scale', 'timeFrame': 'Baseline, 60 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'referencesModule': {'references': [{'pmid': '29284427', 'type': 'DERIVED', 'citation': 'McDonnell PJ, Pflugfelder SC, Stern ME, Hardten DR, Conway T, Villanueva L, Hollander DA. Study design and baseline findings from the progression of ocular findings (PROOF) natural history study of dry eye. BMC Ophthalmol. 2017 Dec 28;17(1):265. doi: 10.1186/s12886-017-0646-5.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'At least 200 dry eye patients (with at least 40% of patients with elevated biomarkers for ocular surface inflammation) will be enrolled at approximately 15-20 sites. Approximately 40-50 patients will be enrolled in the control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms\n* Baseline OSDI score of ≥ 13\n* Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group)\n\nExclusion Criteria:\n\n* Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline\n* History of herpes keratitis or varicella zoster keratitis\n* Any history of allergic conjunctivitis\n* Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye\n* Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK) within 12 months of baseline, or expectation of such surgery within 2 years\n* Patients with known systemic disease\n* Any history of corneal transplant'}, 'identificationModule': {'nctId': 'NCT00833235', 'briefTitle': 'A Natural History Study of Patients With Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MA-RES-08-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with dry eye', 'description': 'No treatment is prescribed for the study. Patient dry eye progression will be followed for up to 60 months. Patients may use artificial tears to treat their dry eye symptoms.', 'interventionNames': ['Other: Artificial Tears']}, {'label': 'Patients with no history of dry eye', 'description': 'No treatment is prescribed for this control group. Patients will be followed for up to 60 months. If needed, patients may use artificial tears.', 'interventionNames': ['Other: Artificial Tears']}], 'interventions': [{'name': 'Artificial Tears', 'type': 'OTHER', 'description': 'Artificial tears (any brand) may be used to treat dry eye symptoms.', 'armGroupLabels': ['Patients with dry eye', 'Patients with no history of dry eye']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Jones Eye Institute', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'North Valley Eye Medical Group, Inc.', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Milauskas Eye Institute', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '80525', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Eye Center of Northern Colorado', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '33904', 'city': 'Cape Coral', 'state': 'Florida', 'country': 'United States', 'facility': 'Cape Coral Eye Center, PA', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}, {'zip': '33770', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'The Eye Institute of West Florida', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Wilmer Eye Institute Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55431', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Eye Consultants, P.A.', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mulqueeny Eye Centers', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Eye Specilaists', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '44141', 'city': 'Brecksville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Eye Clinic', 'geoPoint': {'lat': 41.31978, 'lon': -81.62679}}, {'zip': '19004', 'city': 'Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Ophthalmic Partners Bala', 'geoPoint': {'lat': 40.0109, 'lon': -75.23}}, {'zip': '16066', 'city': 'Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hazleton Eye Specialists'}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Eye Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Alkek Eye Center, Department of Ophthalmology', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77573', 'city': 'League City', 'state': 'Texas', 'country': 'United States', 'facility': 'The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center', 'geoPoint': {'lat': 29.50745, 'lon': -95.09493}}, {'zip': '22102', 'city': 'McLean', 'state': 'Virginia', 'country': 'United States', 'facility': 'See Clearly Vision Group', 'geoPoint': {'lat': 38.93428, 'lon': -77.17748}}], 'overallOfficials': [{'name': 'Tes Ignacio', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}