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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT02358369
Eligibility Criteria:
Key Inclusion Criteria:
* Written informed consent
* At least 18 years of age
* Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
* Best corrected-distance visual acuity score equivalent to 20/80 or better
* Stable visual field
* Central corneal thickness between 490 - 620 micrometers
Inclusion Criteria at the Randomization Visit:
("T" is defined as time and "hr" is defined as hour\[s\])
* IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.
* Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.
* IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.
Key Exclusion Criteria:
* Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
* A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of beta-blocker drops
* Cup-to-disc ratio of greater than 0.8
* Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than Grade 2 based on gonioscopy
* Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
* Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
* Past history of any incisional surgery for glaucoma at any time
* Past history of corneal refractive surgery
* Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
* Current participation in an investigational drug or device study or participation in such a study within 30 days of Screening
* Inability to adequately evaluate the retina
* Participants who will require contact lens use during the study period.
* Participants who currently have punctal occlusion
* Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02358369
Study Brief:
Protocol Section:
NCT02358369