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:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT04884256
Eligibility Criteria:
Inclusion Criteria:
* Pinguecula with a vascularity grade ≥ 3 on a 5-point (0-4) scale.
* Ocular bothersome questionnaire score ≥ 2 on a 5-point (0-4) scale.
* ≥ 18 years of age.
* Able to provide written informed consent and comply with study assessments for the full duration of the study.
Exclusion Criteria:
* Uncontrolled systemic disease, in the opinion of the investigator.
* Active ocular disease other than pinguecula that may confound the study data, including but not limited to severe dry eye disease, pterygium, uncontrolled blepharitis, anterior membrane dystrophy, Salzmann's, glaucoma, or active ocular infection.
* History of ocular herpes disease, iritis/uveitis, in either eye.
* Any ocular surgical procedure within the last 3 months or anticipated ocular surgery during the study, in either eye.
* Anticipated wearing of contact lenses during any portion of the study. Patients, who wear soft contact lenses should discontinue wearing them at least 7 days prior to Day 1 visit. Patients wearing rigid gas permeable or hard contact lenses should discontinue wearing them at least 3 weeks prior to Day 1 visit.
* Female patients who are pregnant, nursing, or planning a pregnancy during the study.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to entry into this study.
* History of myocardial infarction or stroke.
* Any condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
* Known allergy or sensitivity to the study medication(s) or its components.
* Current or anticipated use of topical ophthalmic medications in the study eye. Patients must have discontinued use of ophthalmic medications in the study eye for at least 2 weeks (4 weeks for Restasis® or Xiidra®) prior to Day 1 visit. Artificial tears are allowed in the study eye until 7 days prior to Visit 1 and should not be used during the treatment phase of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04884256
Study Brief:
Protocol Section:
NCT04884256