Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00679718
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2008-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease
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': 'C403315', 'term': 'diquafosol'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'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': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-26', 'studyFirstSubmitDate': '2008-05-15', 'studyFirstSubmitQcDate': '2008-05-16', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Schirmer scores'}, {'measure': 'Corneal staining'}, {'measure': 'Conjunctival staining'}, {'measure': 'Tear break-up time'}, {'measure': 'Change in artificial tear usage'}, {'measure': 'Patient-reported improvement of foreign body sensation'}], 'secondaryOutcomes': [{'measure': 'Visual acuity'}, {'measure': 'Investigator global severity assessment'}, {'measure': 'Patient-reported dry eye symptoms other than foreign body sensation'}, {'measure': 'Biomicroscopy'}, {'measure': 'Ophthalmoscopy'}, {'measure': 'IOP'}]}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Best corrected visual acuity of at least +0.7 ETDRS\n* Six month history of dry eye disease\n* Mild severity in two out of five symptoms\n* Unanesthetized Schirmer score of less than or equal to 7mm\n* Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18\n\nExclusion Criteria:\n\n* Nasal stimulated Schirmer score of less than 3mm\n* Have ongoing ocular infection\n* Have congenitally absent meibomian or lacrimal glands\n* Have had punctal occlusion within a specified time prior to study\n* Wear contact lens and refuse to remove them\n* Have other excluded eye conditions.'}, 'identificationModule': {'nctId': 'NCT00679718', 'briefTitle': 'A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Patients With Moderate to Severe Dry Eye Disease', 'orgStudyIdInfo': {'id': '03-103'}}, 'armsInterventionsModule': {'interventions': [{'name': 'diquafosol tetrasodium (INS365) ophthalmic solution', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}