The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

Prior treatment

• Contraindications to beta-blocker therapy

Other illness

• 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

Other

• 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)

• 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)
• 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
• 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.
• 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
• 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
• 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
• 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