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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755183
• Other study ID #: 08-004-16
• Status: Completed
• Phase: Phase 2
• Start date: July 2008
• Est. completion date: April 2009

Study information

• Verified date: September 2020
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria (subjects must):

• Be = 60 years of age

• Have a corrected visual acuity of LogMAR +0.5 (ETDRS)

• Have a documented history of Meibomian Gland Dysfunction

• Have a TFBUT = 5 seconds

• Have an ocular discomfort score = 1

• Have an IOP = 25 mmHg at Visit 1 in both eyes

• Report use of and/or desire to use an artificial tears

Exclusion Criteria (subjects may not):

• Have contraindications to the use of the study medications

• Have a known allergy or sensitivity to the study medications

• Have any ocular infections, or active ocular inflammation

• Have used ocular medications within 24 hours prior to Visit 1

• Be a current contact lens wearer

• Require the use of any other ophthalmic medication, other than tear substitutes and study medication provided, for the duration of the trial

• Have used systemic or topical antihistamines or steroids 48 hours prior to Visit 1 or require the use of systemic or topical antihistamines or steroids during the course of the study

• Have a history of prostate cancer

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• testosterone ophthalmic solution
testosterone ophthalmic solution for 128 days
• vehicle of testosterone ophthalmic solution
vehicle of testosterone ophthalmic solution for 128 days

Locations

Country	Name	City	State
United States	Ophthalmic Research Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meibomian Gland Secretion Appearance at Visit 4 (Day 168)	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.	168 days
Primary	Ocular Discomfort Score at Visit 4	Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168)	168 days