NCT03660475

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sassani, Joseph S., MD, MHA · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2, single-center, double-masked, randomized, placebo-controlled study to compare the safety and efficacy of Naltrexone Ophthalmic Solution, 0.002% to placebo for the treatment of the signs and symptoms of dry eye in diabetic subjects. Subjects eligible to be randomized will receive one of the following treatments to be administered bilaterally BID for 29 days (from Visit 2 to Visit 5): Naltrexone Ophthalmic Solution, 0.002% or Placebo Ophthalmic Solution (Vehicle). During a 10-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (Vehicle) bilaterally BID. Participants who terminate early during the application period will be asked to complete safety assessments (if the participants agree) prior to study exit. Participants who are terminated early from the study will not be replaced.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Naltrexone	naltrexone formulated as ophthalmic solution
DRUG	Placebos	Placebo ophthalmic solution

Timeline

• Start date: 2018-07-31
• Primary completion: 2018-11-01
• Completion: 2018-11-15
• First posted: 2018-09-06
• Last updated: 2022-12-02
• Results posted: 2022-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study