MedTrace Logo

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

NCT03660475 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-12-02

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Naltrexone

naltrexone formulated as ophthalmic solution

DRUG

Placebos

Placebo ophthalmic solution

Sponsors & Collaborators

  • Sassani, Joseph S., MD, MHA

    lead INDIV

Principal Investigators

  • Eugene B McLaurin, M.D. · Total Eye Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2018-11-01
Completion
2018-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03660475 on ClinicalTrials.gov