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: 17.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.1Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.1Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-003186-24-IT
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-22
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Key Inclusion Criteria:
• Written informed consent has been obtained
• In the opinion of the investigator, based on prior use or on IOP rebound (elevation) during the washout period, patient is a responder to IOP lowering by topical prostamides, prostaglandins, or prostaglandin analogs
• The iridocorneal angle inferiorly in the study eye must be confirmed as being qualified by Reading Center AS-OCT assessment
• 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
• In the investigator’s opinion, either eye can be treated adequately with timolol eye drops as the sole therapy
• In both eyes, at the baseline visit: Hour 0 IOP of = 22 mm Hg and = 32 mm Hg, with difference between eyes of = 5 mm Hg
• In both eyes at Hour 2 at the baseline visit, IOP = 19 mm Hg and = 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
• Contraindications to beta-blocker therapy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety<br>of 2 dose strengths of Bimatoprost SR in patients with open-angle glaucoma<br>(OAG) or ocular hypertension (OHT) after initial and repeated administrations;Secondary Objective: not applicable;Primary end point(s): Study eye time-matched IntraOcular Pressure change from baseline (follow-up minus time-matched baseline) at each hour evaluated (Hours 0 and 2).;Timepoint(s) of evaluation of this end point: Mean IOP change from baseline will be compared between each Bimatoprost SR dose strength and timolol for each hour (Hours 0 and 2) using the ITT population. The comparisons at Week 12 will be considered the primary analysis. IOP evaluations will occur at 2 timepoints: Hour 0 (08:00 ± 1 hour) and Hour 2 (Hour 0 + 2 hours [± 30 min]), and on Days 2; 4 and 8 after each administration and at Weeks 2, 6, 12, 15, 18, 22, 28, 31, 34, 38, 44, 48, and 52

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): time-matched lowering of IntraOcular Pressure.;Timepoint(s) of evaluation of this end point: at scheduled visits (Weeks 2, 6, and 12) and hours for (1) time-matched IOP and (2) time-matched IOP change from baseline.