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

Phase 2

Completed

• Conditions: Meibomian Gland Dysfunction
• Interventions: Drug: testosterone ophthalmic solution; Drug: vehicle of testosterone ophthalmic solution

• Registration Number: NCT00755183
• Lead Sponsor: ORA, Inc.

Brief 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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Disposition First Submitted: 2012-03-15
• Disposition First Submitted QC: 2012-03-15
• Disposition First Posted: 2012-03-19
• Status Verified: 2020-09
• Results First Submitted: 2020-09-29
• Results First Submitted QC: 2020-09-29
• Last Update Submitted: 2020-09-29
• Results First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
testosterone ophthalmic solution	testosterone ophthalmic solution	testosterone ophthalmic solution 0.03%
vehicle	vehicle of testosterone ophthalmic solution	vehicle of testosterone ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Meibomian Gland Secretion Appearance at Visit 4 (Day 168)	168 days	The average of the secretion color, quality, and viscosity of the worst gland in the worst eye. All scales were numerical analog, 0-3, where 0=normal and 3=worst.
Ocular Discomfort Score at Visit 4	168 days	Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168)

Trial Locations

Locations (1)

Ophthalmic Research Associates; 🇺🇸 Andover, Massachusetts, United States