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

Ora, Inc.

Status and phase

Completed

Phase 2

Conditions

Meibomian Gland Dysfunction

Treatments

Drug: vehicle of testosterone ophthalmic solution

Drug: testosterone ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT00755183

08-004-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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