Status:
COMPLETED
A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Dry Eye Disease
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.
Eligibility Criteria
Inclusion
- Best corrected visual acuity of at least +0.7 ETDRS
- Six month history of dry eye disease
- Mild severity in two out of five symptoms
- Unanesthetized Schirmer score of less than or equal to 7mm
- 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
Exclusion
- Nasal stimulated Schirmer score of less than 3mm
- Have ongoing ocular infection
- Have congenitally absent meibomian or lacrimal glands
- Have had punctal occlusion within a specified time prior to study
- Wear contact lens and refuse to remove them
- Have other excluded eye conditions.
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2000
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00679718
Start Date
January 1 2000
End Date
July 1 2000
Last Update
August 27 2015
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