Expired Study
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Andover, Massachusetts 01810


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.


Study summary:

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.


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


NCT ID:

NCT00755183


Primary Contact:

Principal Investigator
H. Jerome Crampton, MD
ORA, Inc.


Backup Contact:

N/A


Location Contact:

Andover, Massachusetts 01810
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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