Bimatoprost for Ocular hypertension|Open-angle glaucoma

Inclusion criteria

• {"criterion_text":"- Diagnosis of either OAG (ie, primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in each eye and both eyes require IOP-lowering treatment (Note: diagnosis does not have to be the same in both eyes)"}
• {"criterion_text":"- In the investigator’s opinion, either eye can be treated adequately with topical ophthalmic beta-blocker (eg, timolol) eye drops as the sole therapy In the investigator’s opinion, either eye can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan, Travatan) eye drops as the sole therapy"}
• {"criterion_text":"- The iridocorneal angle in the study eye must be independently confirmed as being qualified by 2 ophthalmologists using the following criteria: a. Shaffer Grade ≥ 3 on clinical gonioscopy of the inferior angle b. Peripheral anterior chamber depth by Van Herick examination ≥ 1/2 corneal thickness. Note: The independent eligibility assessments must both agree that the Shaffer grade is ≥ 3 and the Van Herick grade is ≥ 1/2 corneal thickness."}
• {"criterion_text":"- At the Baseline visit: Hour 0 IOP in the study eye of ≥ 22 mm Hg and ≤ 32 mm Hg, and in the fellow eye of ≤ 32 mm Hg"}
• {"criterion_text":"- At the Baseline visit: Hour 2 IOP in the study eye of ≥ 19 mm Hg and ≤ 32 mm Hg, and in the fellow eye of ≤ 32 mm Hg"}
• {"criterion_text":"- By the Baseline visit, the final central endothelial cell density in both eyes must be confirmed as being qualified by Reading Center assessment, with at least one eye qualified for inclusion as the study eye"}
• {"criterion_text":"- In the investigator’s opinion, either eye can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan, Travatan) eye drops as the sole therapy"}

Exclusion criteria

• {"criterion_text":"- The following surgical history: a. History or evidence of complicated cataract surgery in the study eye: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc) Note: history of uncomplicated cataract surgery is not an exclusion. b. History of phakic IOL insertion for refractive error correction in the study eye"}
• {"criterion_text":"- In the investigator’s opinion, patient is nonresponsive to topical ophthalmic beta-blockers and/or topical prostamides, prostaglandins, or prostaglandin analogs (eg, LUMIGAN, Xalatan, Travatan)"}
• {"criterion_text":"- Contraindications to beta-blocker therapy"}

Primary endpoints

• {"endpoint_text":"- Study eye time-matched IOP change from baseline (follow-up minus time-matched baseline) at each hour evaluated (Hours 0 and 2).","definition_or_measurement_approach":"Change from baseline in study eye time-matched intraocular pressure (IOP) at specified hours (Hours 0 and 2); calculated as follow-up minus time-matched baseline IOP."}

Secondary endpoints

• {"endpoint_text":"- Time-matched IOP","definition_or_measurement_approach":"Time-matched intraocular pressure measurements (IOP) at specified study time points."}

Germany

Earliest CTIS Part Ii Submission Date

10-12-2024

Latest Decision Or Authorization Date

04-06-2025

Processing Time Days

176

Number Of Sites

2

Number Of Participants

3

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"United States","full_name":"Doheny Eye Institute","duties_or_roles":"Perform cell density analysis","organisation_type":"Educational Institution"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Lab services for Safety labs","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Blue Sky Elearn LLC","duties_or_roles":"Provide web based training portal for the study","organisation_type":"Non-Pharmaceutical company"}