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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT04620135
Eligibility Criteria:
Inclusion Criteria:
* 20 years of age or older
* Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye was acceptable)
* Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and \< 30 mmHg in both eyes at screening visit
* For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and \< 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 15 mmHg and \< 35 mmHg at 11:00 and 16:00 hour (in the same eye).
* For OHT eyes, unmedicated (post washout) IOP ≥ 22 mmHg and \< 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 22 mmHg and \< 35 mmHg at 11:00 and 16:00 hours (in the same eye)
* Best-corrected visual acuity (BCVA) +0.7 log MAR or better (20/100 Snellen or better or 0.20 or better in decimal unit) in each eye
* Willingness and ability to give signed informed consent and follow study instructions
Exclusion Criteria:
* Clinically significant ocular disease
* Retinal diseases that may progress during the study period
* Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
* Previous glaucoma intraocular surgery
* Refractive surgery in either eye
* Ocular hyperemia score of moderate (+2) or severe (+3) at Qualification Visit #2
* Ocular trauma
* Ocular infection or inflammation
* Any corneal disease that may confound assessment
* Evidence of corneal deposits or cornea verticillata
* Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic.
* Mean central corneal thickness \>620 um
* Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g. keratoconus)
* Cannot demonstrate proper delivery of the eye drop
* Clinically significant systemic disease
* Participation in any investigational study within 30 days prior to screening
* Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04620135
Study Brief:
Protocol Section:
NCT04620135