Assessment of the Efficacy of Ocular Dipyridamole in the Treatment of Dry Eye Symptomology in Subjects With Pterygium

Study Overview
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Brief Summary
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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.

Conditions
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Dry Eye Syndromes, Pterygium

Intervention / Treatment
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* Drug: Dipyridamole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide informed consent. Ineligible or refused surgical excision, or had recurrence of pterygium following surgical excision Able to follow the study instructions, including application of the study product Agreement not to change the type of lubricating eye drops used (if any) during their participation in the study. Assessed as having at least pterygium stage 0-1 (pinguecula) based on Johnston, Williams & Sheppard's classification for pterygium Concomitant dry eye symptoms, as determined by one or more of the following Subject interview (modified Ocular Surface Disease Index test), Tearing, Itch / foreign body sensation, Positive Fluorescein test, Positive TBUT test, Positive Tear meniscus test Exclusion Criteria: Inability to provide informed consent Dry eye due to other factors Known lacrimal obstruction Contact lens wearers Non-corrected refraction Allergy or sensitivity to dipyridamole or excipients Use of dipyridamole in the last 6 months Other eye conditions (i.e. active ocular infection, herpes keratitis in last 6 months, corneal disorder abnormality excluding pterygium, history of ocular acne rosacea, blepharitis) which would impact results Diagnosis of ALS (Amyotrophic lateral sclerosis) Existing conditions which are contraindicated or precaution in use of dipyridamole or excipients Use of eye drops (other than ocular lubricants) Pregnant or breastfeeding Inability to apply the medical product or follow the study procedures Anything that the PI thinks would impact the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Dipyridamole eye drops 8.48 mg in 100ml 1 drop three times a day for 1 year | Drug: Dipyridamole<br> <br> |
| Placebo Comparator: Placebo<br>Fluorescein in Active Vehicle 1 drop three times a day for 1 year | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Fluorescein - Improvement of one of the quadrants sufficient to change the severity rating TBUT (Tear Breakup time) - Decreased by at least 1 second Tear meniscus test - Increase of at least 0.2mm | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 months |