Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 20 for:    single-center testosterone
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00755183
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Drug: testosterone ophthalmic solution Drug: vehicle of testosterone ophthalmic solution Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : July 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Meibomian Gland Secretion Appearance at Visit 4 (Day 168) [ Time Frame: 168 days ]
    The average of the secretion color, quality, and viscosity of the worst gland in the worst eye. All scales were numerical analog, 0-3, where 0=normal and 3=worst.

  2. Ocular Discomfort Score at Visit 4 [ Time Frame: 168 days ]
    Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755183


Locations
Layout table for location information
United States, Massachusetts
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
ORA, Inc.
Investigators
Layout table for investigator information
Principal Investigator: H. Jerome Crampton, MD ORA, Inc.
Layout table for additonal information
Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT00755183    
Other Study ID Numbers: 08-004-16
First Posted: September 18, 2008    Key Record Dates
Results First Posted: October 22, 2020
Last Update Posted: October 22, 2020
Last Verified: September 2020
Keywords provided by ORA, Inc.:
Meibomian Gland Dysfunction
Dry Eye Syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Meibomian Gland Dysfunction
Eyelid Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents