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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.
Sponsor:
Information provided by (Responsible Party):
H. Jerome Crampton, ORA, Inc.
ClinicalTrials.gov Identifier:
NCT00755183
First received: September 17, 2008
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by ORA, Inc.:

Primary Outcome Measures:
  • meibomian glad secretion [ Time Frame: 128 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comfort [ Time Frame: 128 days ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755183

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

No publications provided

Responsible Party: H. Jerome Crampton, Doctor, ORA, Inc.
ClinicalTrials.gov Identifier: NCT00755183     History of Changes
Other Study ID Numbers: 08-004-16
Study First Received: September 17, 2008
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 22, 2013