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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT01114893
Eligibility Criteria:
Inclusion Criteria:
1. either sex and any race/ethnicity, ≥18 years old
2. diagnosed with open-angle glaucoma, and/or ocular hypertension
3. meets the following IOP entry criteria:
* Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
* Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
4. satisfies all informed consent requirements; able to read, sign and date the informed consent
Exclusion Criteria:
1. females of childbearing potential not meeting protocol conditions
2. angle grade less than Grade 2 in either eye
3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
4. severe central visual field loss in either eye
5. any abnormality preventing reliable applanation tonometry in either eye
6. hypersensitivity to prostaglandin analogues or to any component of the study medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01114893
Study Brief:
Protocol Section:
NCT01114893