Status:
COMPLETED
Safety and Efficacy Study of a Testosterone Eye Drop for the Treatment of Meibomian Gland Dysfunction
Lead Sponsor:
ORA, Inc.
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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 evapor...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00755183
Start Date
July 1 2008
End Date
April 1 2009
Last Update
October 22 2020
Active Locations (1)
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1
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810