A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic structures are characteristics of the disease. AG-86893 is an eye drop being developed to treat hyperemia (redness) and growth of the pterygium. Hypothesis 1. AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety profile as measured by the incidence and severity of adverse events (AEs) compared with vehicle 2. At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
One drop, three times daily to the study eye for 28 days
One drop, three times daily to the study eye for 28 days
One drop, three times daily to the study eye for 28 days
M.T. Coroneo Pty Ltd
Randwick, New South Wales, Australia
H2Vision Centre
Sippy Downs, Queensland, Australia
Bendigo Eye Clinic
Bendigo, Victoria, Australia
Essendon Eye Clinic
Essendon, Victoria, Australia
The Geelong Eye Centre
Waurn Ponds, Victoria, Australia
Lions Eye Institute
Nedlands, Western Australia, Australia
Change From Baseline in Overall Conjunctival Hyperemia Score
Assessed by digital ocular photography; each quadrant of the eye (superior, inferior, nasal, temporal) will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. The overall conjunctival score is the average of the four quadrants. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement.
Time frame: Baseline and Day 28
Change From Baseline in Conjunctival Hyperemia Score in the Quadrant With the Pterygium
Assessed by digital ocular photography; the quadrant with the pterygium will be scored using a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe) and graded by a reading center. Assessments are made by subtracting the score at Baseline from the score on Day 28. An increase in value indicates worsening of hyperemia, while a decrease indicates improvement.
Time frame: Baseline and Day 28
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