Overview

Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Status:
Completed
Trial end date:
2001-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- best corrected visual acuity in both eyes of at least +0.7

- six-month documented history of dry eye disease

- at least mild severity in 2 of the 4 dry eye symptoms

- unanesthetized Schirmer score of less than or equal to 7mm

- corneal fluorescein staining of greater than or equal to 4 (out of 15)

Exclusion Criteria:

- nasally stimulated Schirmer score of less than 3mm in subjects with an initial
Schirmer score of 0mm

- ongoing contact lens wear

- current topical ophthalmic medication use