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: 100000004853; 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-AT
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-15
• 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 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 in the study eye must be independently confirmed as being qualified 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

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 2 dose strengths of Bimatoprost SR in patients with open-angle glaucoma (OAG) or ocular<br> hypertension (OHT) after initial and repeated administrations<br> ;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).;<br> 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<br>

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.