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 - Full Text View

Sponsor:	ORA, Inc.
Collaborator:	Crampton, H. Jerome, M.D.
Information provided by:	ORA, Inc.
ClinicalTrials.gov Identifier:	NCT00755183

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

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 ]

Estimated Enrollment:	60
Study Start Date:	August 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental testosterone ophthalmic solution	Drug: testosterone ophthalmic solution testosterone ophthalmic solution for 128 days
2: Placebo Comparator 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

ORA, Inc.

Crampton, H. Jerome, M.D.

Investigators

Principal Investigator:

H. Jerome Crampton, MD

ORA, Inc.

More Information

No publications provided

Responsible Party:	Crampton, H Jerome, M.D. ( H. Jerome Crampton, MD )
Study ID Numbers:	08-004-16
Study First Received:	September 17, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00755183 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ORA, Inc.:

Meibomian Gland Dysfunction
Dry Eye Syndrome

Additional relevant MeSH terms:

Anabolic Agents
Testosterone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Pharmacologic Actions
Androgens
Testosterone 17 beta-cypionate

ClinicalTrials.gov processed this record on November 25, 2009