Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT02782260
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02782260
Study Brief:
Protocol Section:
NCT02782260