MedTrace Logo

Safety and Efficacy Study of a Testosterone Eye Drop for the Treatment of Meibomian Gland Dysfunction

NCT00755183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-22

Study results available
· View outcomes & findings →

Summary

The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.

Conditions

  • Meibomian Gland Dysfunction

Interventions

DRUG

testosterone ophthalmic solution

testosterone ophthalmic solution for 128 days

DRUG

vehicle of testosterone ophthalmic solution

vehicle of testosterone ophthalmic solution for 128 days

Sponsors & Collaborators

  • ORA, Inc.

    lead INDUSTRY

Principal Investigators

  • H. Jerome Crampton, MD · ORA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00755183 on ClinicalTrials.gov