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

NCT02782260 | Unknown Phase 2

• 1 other identifier: 0064-16-WOMC
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Dry Eye Syndromes; Pterygium

Outcome Measures

Primary Outcomes (2)

• 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

  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 Outcomes (1)

• A minimum significant reversion of pterygia relative to baseline or cessation of growth of pterygium

  12 months

Study Arms (2)

Active

EXPERIMENTAL

Dipyridamole eye drops 8.48 mg in 100ml 1 drop three times a day for 1 year

Drug: Dipyridamole

Placebo

PLACEBO COMPARATOR

Fluorescein in Active Vehicle 1 drop three times a day for 1 year

Drug: Placebo

Interventions

Dipyridamole DRUG

Active

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ariel University: lead

MeSH Terms

Conditions

Dry Eye Syndromes; Pterygium

Interventions

Dipyridamole

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Conjunctival Diseases

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 25, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: May 25, 2016

Record last verified: 2016-05