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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Dipyridamole eye drops 8.48 mg in 100ml 1 drop three times a day for 1 year |
|
| Placebo | Placebo Comparator | Fluorescein in Active Vehicle 1 drop three times a day for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dipyridamole | Drug |
| ||
| Placebo |
| 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:
| 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
| 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003229 | Conjunctival Diseases |
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| ID | Term |
|---|---|
| D004176 | Dipyridamole |
| ID | Term |
|---|---|
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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