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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: testosterone ophthalmic solution
* Drug: vehicle of testosterone ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: testosterone ophthalmic solution<br>testosterone ophthalmic solution 0.03% | Drug: testosterone ophthalmic solution<br>* testosterone ophthalmic solution for 128 days<br>|
| Placebo Comparator: vehicle<br>vehicle of testosterone ophthalmic solution | Drug: vehicle of testosterone ophthalmic solution<br>* vehicle of testosterone ophthalmic solution for 128 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meibomian Gland Dysfunction, Dry Eye Syndrome