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

Ariel University

Status and phase

Unknown

Phase 2

Conditions

Dry Eye Syndromes

Pterygium

Treatments

Drug: Dipyridamole

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02782260

0064-16-WOMC

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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