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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
testosterone ophthalmic solution for 128 days
vehicle of testosterone ophthalmic solution for 128 days
Ophthalmic Research Associates
Andover, Massachusetts, United States
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.
Time frame: 168 days
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)
Time frame: 168 days
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