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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02325518
Eligibility Criteria:
Inclusion Criteria:
* Understand the nature of the study and sign informed consent.
* Diagnosis of open angle glaucoma or ocular hypertension.
* Currently on PGA monotherapy or PGA + alpha-1/beta blocker or PGA + alpha-2 agonist at screening visit, and allowed to instill only PGA for 4 weeks until the baseline visit.
* Intraocular pressure (IOP) ≥ 15 mmHg (at least one same eye) at the baseline visit.
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* History of bronchial asthma, bronchospasm, or serious chronic obstruction pulmonary disease.
* Uncontrolled heart failure, sinus bradycardia, A-V block (II, III grade), cardiogenic shock, right heart failure due to pulmonary hypertension or congestive heart failure.
* History of hypersensitivity to any of the excipients of the study medications.
* Severe renal function disorders, diabetic ketoacidosis and metabolic acidosis, uncontrolled diabetes, or hepatic disorders.
* Corneal disorder or history of chronic, recurrent or current severe inflammatory eye disease in either eye.
* History of ocular trauma in either eye within 6 months prior to the screening examination.
* Ocular infection or ocular inflammation in either eye.
* History of or current clinically significant or progressive retinal disease in either eye.
* Intraocular surgery in either eye within 6 months prior to the screening examination.
* Ocular laser surgery in either eye within 3 months prior to the screening examination.
* Any abnormality preventing reliable applanation tonometry of either eye.
* Best-corrected visual acuity (BCVA) worse than 0.2 score (decimal visual acuity) in either eye.
* Severe visual field loss in either eye.
* Use of prohibited medication, as specified in the protocol.
* Pregnant, lactating, or intending to become pregnant during the study period.
* Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the screening examination.
* History of or current evidence of a severe illness or any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
* Other protocol-specified exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02325518
Study Brief:
Protocol Section:
NCT02325518