Effect of Topical Naltrexone Ophthalmic Solution on the Signs and Symptoms of Dry Eye in Diabetic Subjects

Summary

The objective of this exploratory study is to determine the safety and efficacy of 0.002% Naltrexone Ophthalmic Solution, compared to placebo for the treatment of the signs and symptoms of dry eye in diabetic subjects.

Timeline

Start

2018-07-31

Primary completion

2018-11-01

Completion

2018-11-15

Outcome

Missed primary endpoint

registry analysis (superiority test); Naltrexone vs Placebo; p = 0.967; t-test, 2 sided NCT03660475 ↗

Drugs

Indications