A Phase 2 interventional study of Dipyridamole and Placebo in Dry Eye Syndromes and Pterygium, sponsored by Ariel University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-25.
Sponsored by Ariel University · Phase 2, Interventional, and Treatment
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Ariel University is the lead sponsor of 29 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Dipyridamole eye drops 8.48 mg in 100ml 1 drop three times a day for 1 year
Drug: Dipyridamole
Fluorescein in Active Vehicle 1 drop three times a day for 1 year
Drug: Placebo
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Ariel University