CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Naltrexone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03660475
NCT03660475Phase 2Completed
CompareCT.gov

A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of Topical Naltrexone Ophthalmic Solution on the Signs and Symptoms of Dry Eye in Diabetic Subjects

Sassani, Joseph S., MD, MHA·interventional·Posted Sep 6, 2018·Updated Dec 2, 2022

In Brief

A Phase 2 clinical trial evaluating Naltrexone and Placebos for Dry Eye Disease. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 6, 2018
Enrollment StartJul 31, 2018
Primary CompletionNov 1, 2018
Study CompletionNov 15, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.8 years ago

Interventions

Naltrexonedrug

naltrexone formulated as ophthalmic solution

Placebosdrug

Placebo ophthalmic solution