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

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 Overview

• Status: Unknown
• Conditions: Dry Eye Syndromes; Pterygium
• Intervention / Treatment: Drug: Placebo; Drug: Dipyridamole

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ariel University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 24, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pterygium; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Phosphodiesterase Inhibitors; Dipyridamole
• Other Study ID Numbers: 0064-16-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided