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

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.

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.

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