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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Jerome Crampton; ORA, Inc.
• Treatments: Methyltestosterone; Ophthalmic Solutions; Pharmaceutical Solutions; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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