Subjects with pterygium and associated dry eye symptoms (DES) are randomized into an active cohort (receiving ocular administration of Dipyridamole) or placebo cohort (ocular administration of vehicle). Monthly follow up is conducted for 12 months. Testing conducted at follow up will assess dry eye / pterygium symptoms and endpoints and review the efficacy of the intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Assess the changes in dry eye parameters via a change in tear secretion rate
Change in the tear secretion rate will be defined by successful change in parameters of ONE of the following testing methods compared to baseline: 1. Fluorescein - Improvement of one of the quadrants sufficient to change the severity rating 2. TBUT (Tear Breakup time) - Decreased by at least 1 second 3. Tear meniscus test - Increase of at least 0.2mm
Time frame: 6 months
Assess the changes in dry eye parameters via reduction in dry eye symptomology.
Reduction in dry eye symptomology will be defined as ONE of the following relative to baseline, determined by subject feedback * An improvement in questionnaire scores * Specified improvement in blurred vision grading * Specified improvement in tearing grading * Specified improvement in itch / foreign body (grittiness) sensation grading.
Time frame: 6 months
A minimum significant reversion of pterygia relative to baseline or cessation of growth of pterygium
Minimum significant reversion will be defined as a decrease in vascularisation, or a measurable decrease from baseline of OCT (Ocular Coherence Tomography) measured parameters (height or width).
Time frame: 12 months
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