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

This study has been completed.
Information provided by (Responsible Party):
H. Jerome Crampton, ORA, Inc. Identifier:
First received: September 17, 2008
Last updated: March 15, 2012
Last verified: March 2012
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.

Condition Intervention Phase
Meibomian Gland Dysfunction
Drug: testosterone ophthalmic solution
Drug: vehicle of testosterone ophthalmic solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by ORA, Inc.:

Primary Outcome Measures:
  • meibomian glad secretion [ Time Frame: 128 days ]

Secondary Outcome Measures:
  • comfort [ Time Frame: 128 days ]

Enrollment: 60
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00755183

United States, Massachusetts
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
H. Jerome Crampton
Principal Investigator: H. Jerome Crampton, MD ORA, Inc.
  More Information

Responsible Party: H. Jerome Crampton, Doctor, ORA, Inc. Identifier: NCT00755183     History of Changes
Other Study ID Numbers: 08-004-16
Study First Received: September 17, 2008
Last Updated: March 15, 2012

Keywords provided by ORA, Inc.:
Meibomian Gland Dysfunction
Dry Eye Syndrome

Additional relevant MeSH terms:
Pharmaceutical Solutions
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Ophthalmic Solutions
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on April 26, 2017