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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT00767494
Eligibility Criteria:
Inclusion Criteria:
* 18 YOA or older
* Either gender or any race
* OAG or OHT
* Currently on stable (at least 4 weeks) IOP lowering medication
* IOP at screening visit ≥ 18mmHg in at least one eye
* Mean IOP in same eye (at both eligibility 1\&2 visits
* 24 and 36 mmHg at 9AM
* 21 and 36 mmHg at 11AM and 4PM
* Able to discontinue use of IOP lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1
Exclusion Criteria:
Related to disease condition being investigated (OAG or OHT) in either eye
* Severe central visual field loss
* Angle shaffer grade \< 2
* C/D ratio \>0.8(horizontal or vertical measurement)
Related to ocular patient history or current ocular condition in either eye
* BSCVA worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
* Ocular infection or inflammation or laser surgery within the last 3 months
* Intraocular surgery or trauma with the last 6 months
* Any abnormality preventing reliable applanation tonometry
* History or chronic, recurrently or current severe inflammatory disease
* History of or current clinically significant or progressive retinal disease
* History of or current ocular pathology(including severe dry eye) that would affect the conduct of the study
Related to systemic or ocular medication in either eye
* Allergy/hypersensitivity to study medications
* Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period
* Use of oral CAIs during the study
* Recent use (\<4 weeks prior to the study) of Aspirin (\>1 gram)
* Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP
* Therapy with another investigational agent within 30 days prior to the Screening Visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00767494
Study Brief:
Protocol Section:
NCT00767494