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

NCT ID: NCT02782260

Last Updated: 2016-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active

Dipyridamole eye drops 8.48 mg in 100ml

1 drop three times a day for 1 year

Group Type: EXPERIMENTAL

Dipyridamole

Intervention Type: DRUG

Placebo

Fluorescein in Active Vehicle

1 drop three times a day for 1 year

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Dipyridamole

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ariel University

OTHER

Sponsor Role: lead

Responsible Party

Lily Karmona

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

0064-16-WOMC

Identifier Type: -

Identifier Source: org_study_id