The Efficacy and Safety of Bimatoprost SR in Patients with Open-angle Glaucoma or Ocular Hypertensio

Phase 1

• Conditions: Open-angle Glaucoma and Ocular Hypertension; MedDRA version: 20.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-003037-26-HU
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

• Written informed consent has been obtained
• 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 indipendently confirmed as being qualified by 2 opthalmologists using the following criteria:
- Shaffer Grade > 3 on clinical gonioscopy of the inferior angle
- Peripheral anterior chamber depth by Van Herick examination = 1/2 corneal thickness
• By the Baseline visit: the final central endothelial cell density in both eyes must be confirmed as being qualified by Reading Center assessment
• Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, 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
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

• History of cataract surgery in the study eye resulting in anterior chamber intraocular lens implant (IOL), phakic IOL, sulcus IOL, aphakia, or complications (eg, a posterior capsular tear [with or without vitreous loss], iris trauma, etc)
• 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)
• Contraindications to beta-blocker therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified