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 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT01309204
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
* Meet qualifying IOP entry criteria.
* Able to understand and sign an informed consent form.
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
* Severe central visual field loss.
* Can not safely undergo the initial washout period and discontinue use of all IOP-lowering ocular medication(s) for the minimum specified period prior to Eligibility Visit 1.
* Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
* Chronic, recurrent or severe inflammatory eye disease.
* Ocular trauma within the preceding 6 months.
* Ocular infection or inflammation within the preceding 3 months.
* Clinically significant or progressive retinal disease.
* Other ocular pathology.
* Intraocular surgery within the 6 months prior to entry.
* Ocular laser surgery within the 3 months prior to entry.
* Any abnormality preventing reliable applanation tonometry.
* Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
* Recent use of high-dose (\>1 gram daily) salicylate therapy.
* Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist.
* Other protocol-specified exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01309204
Study Brief:
Protocol Section:
NCT01309204