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 @ 12:30 PM
Ignite Modification Date:
2025-12-24 @ 12:30 PM
NCT ID:
NCT00947661
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged ≥ 18 years.
* Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG).
* Unmedicated IOP ≥ 22 mmHg in one or both eyes.
* Given informed consent.
* Women of child bearing potential practicing an acceptable method of birth control with a negative urine pregnancy test.
Exclusion Criteria:
* Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
* Intraocular conventional surgery or laser surgery within the past six months.
* Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months.
* Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy.
* Ocular trauma within the past 3 months.
* Progressive retinal or optic nerve disease apart from glaucoma.
* Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye.
* Any abnormality preventing stable applanation tonometry.
* Use of contact lens for the duration of the study.
* Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber.
* Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications is not judged safe.
* Clinically significant systemic disease which might interfere with the study.
* History of non-compliance to medical regimens or unwilling to comply with the study protocol.
* Participation in another clinical study within the last thirty (30) days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00947661
Study Brief:
Protocol Section:
NCT00947661