Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-31 @ 8:16 AM
Study NCT ID:
NCT00037661
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2002-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2002-05-18', 'studyFirstSubmitQcDate': '2002-05-19', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['dry eye'], 'conditions': ['Keratoconjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months\n* had intermittent or regular artificial tear use within past 3 months\n\nExclusion Criteria:\n\n* had LASIK surgery\n* had punctal occlusion or cauterization within last 3 months"}, 'identificationModule': {'nctId': 'NCT00037661', 'briefTitle': 'Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "Double-Masked, Randomized, Placebo-Controlled Study of Efficacy Parameter Following Administration of INS365 Ophthalmic Solution or Placebo in a Controlled Adverse Environment (CAE) Chamber in Subjects With Non-Sjogren's Associated Dry Eye", 'orgStudyIdInfo': {'id': '03-108'}}, 'armsInterventionsModule': {'interventions': [{'name': 'INS365 Ophthalmic Solution', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}