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.

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Drug: testosterone ophthalmic solution; Drug: vehicle of testosterone ophthalmic solution

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Ophthalmic Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: testosterone ophthalmic solution; testosterone ophthalmic solution 0.03%	Drug: testosterone ophthalmic solution; testosterone ophthalmic solution for 128 days
Placebo Comparator: vehicle; vehicle of testosterone ophthalmic solution	Drug: vehicle of testosterone ophthalmic solution; vehicle of testosterone ophthalmic solution for 128 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ORA, Inc.
• Investigators: Principal Investigator: H. Jerome Crampton, MD, ORA, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: September 17, 2008
• First Submitted That Met QC Criteria: September 17, 2008
• First Posted (Estimate): September 18, 2008

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Dry Eye Syndrome; Meibomian Gland Dysfunction
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: 08-004-16