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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT01144494
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be 19 years of age or older
* Subjects must exhibit a history of untreated IOPs between 21 and 35 mmHg (inclusive)
Exclusion Criteria:
* Age less than nineteen years old
* Women who are pregnant, lactating or of childbearing potential who are not using birth control measures.
* Aphakia or pseudophakia
* Best corrected visual acuity worse than 20/60 in either eye
* Chronic or recurrent severe ocular inflammatory disease
* Ocular infection or inflammation within (3) months of screening visit.
* History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
* Any abnormality preventing reliable tonometry of either eye.
* Previous exposure to: beta-adrenergic antagonists, topical prostaglandin analogues within six (6) weeks of the baseline visit; α-adrenergic agonists within two (2) weeks of the baseline visit; and cholinergic agonists and carbonic anhydrase inhibitors within five (5) days of the treatment initiation visit.
* History of any severe ocular pathology (including severe dry eye) that would prelude the administration of a topical beta blocker, carbonic anhydrase inhibitor, or a topical prostaglandin.
* Any eye with a cup-to-disc ratio greater than 0.8.
* History of intraocular surgery
* History of ocular laser surgery
* History of severe or serious hypersensitivity to brimonidine or its vehicle.
* History of severe, unstable, or uncontrolled cardiovascular, hepatic or renal disease.
* History of bronchial asthma or chronic obstructive pulmonary disease (COPD).
* Less than one month (prior to baseline) stable dosing regimen of any non-glaucoma medication that would affect IOP.
* Gonioscopy angle \< 2.
* Inability to be dosed with treatment medication
* Inability to discontinue contact lens wear.
* Therapy with any investigational agent within 30 days of screening.
* Use of any additional topical or systemic adjunctive ocular hypotensive medications during the study.
* History of open angle glaucoma (either primary open angle glaucoma or other cause of open angle glaucoma) or narrow angle glaucoma.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01144494
Study Brief:
Protocol Section:
NCT01144494