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