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

Primary Purpose

Meibomian Gland Dysfunction

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

testosterone ophthalmic solution

vehicle of testosterone ophthalmic solution

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Meibomian Gland Dysfunction, Dry Eye Syndrome

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ophthalmic Research Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

testosterone ophthalmic solution

vehicle

Arm Description

testosterone ophthalmic solution 0.03%

vehicle of testosterone ophthalmic solution

Outcomes

Primary Outcome Measures

Meibomian Gland Secretion Appearance at Visit 4 (Day 168)

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.

Ocular Discomfort Score at Visit 4

Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168)

Secondary Outcome Measures

Full Information

NCT ID

NCT00755183

First Posted

September 17, 2008

Last Updated

September 29, 2020

Sponsor

ORA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00755183

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ORA, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meibomian Gland Dysfunction

Keywords

Meibomian Gland Dysfunction, Dry Eye Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

testosterone ophthalmic solution

Arm Type

Experimental

Arm Description

testosterone ophthalmic solution 0.03%

Arm Title

vehicle

Arm Type

Placebo Comparator

Arm Description

vehicle of testosterone ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

testosterone ophthalmic solution

Intervention Description

testosterone ophthalmic solution for 128 days

Intervention Type

Drug

Intervention Name(s)

vehicle of testosterone ophthalmic solution

Intervention Description

vehicle of testosterone ophthalmic solution for 128 days

Primary Outcome Measure Information:

Title

Meibomian Gland Secretion Appearance at Visit 4 (Day 168)

Description

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.

Time Frame

168 days

Title

Ocular Discomfort Score at Visit 4

Description

Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168)

Time Frame

168 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

H. Jerome Crampton, MD

Organizational Affiliation

ORA, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmic Research Associates

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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