NCT00755183

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

A Single-Center, Double-Masked, Randomized, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Testosterone 0.03% Ophthalmic Solution Compared to Vehicle for the Treatment of Meibomian Gland Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: ORA, Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. The lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid margin; 4) prevent the contamination of the tear film by sebaceous lipids; 5) prevent damage to the skin of the lid margin. In dry eye syndrome, blepharitis, meibomian gland dysfunction, and meibomitis the glands are the central pathophysiology of disease and thus a potential target for therapy.

Conditions

• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DRUG	testosterone ophthalmic solution	testosterone ophthalmic solution for 128 days
DRUG	vehicle of testosterone ophthalmic solution	vehicle of testosterone ophthalmic solution for 128 days

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-09-18
• Last updated: 2020-10-22
• Results posted: 2020-10-22

Locations

1 site across 1 country: United States