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The Efficacy and Safety of Bimatoprost SR in Patients with Open-Angle Glaucoma or Ocular Hypertension
Registry ID: PHRR150513-001003
Secondary Identification Number: 192024-091; 2015-CT0275


Scientific Title

The Efficacy and Safety of Bimatoprost SR in Patients with Open-Angle Glaucoma or Ocular Hypertension

Project Description

a randomized, patient and efficacy evaluator-masked, parallel-group comparison to evaluate the safety and IOP-lowering effects of repeated administrations of 10 μg or 15 μg Bimatoprost SR in patients with OAG or OHT and open iridocorneal angles inferiorly in the study eye by clinical gonioscopy.

NUHRA Details
NUHRA Regime NUHRA Classification NUHRA Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Project Duration
Start Date Duration in Months Target Completion Date Actual Completion Date
2015-06-01 22 2017-04-01 0000-00-00
Project Status

Ongoing

Implementing Agency (Primary Sponsor)

Name of Institution Classification Region LTO #
Allergan (North America) Private Business United States of America N/A

Cooperating Agency (Secondary Sponsor)

Name of Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR CDRR-NCR-CRO-4

Funding Agency (Sources of Monetary or Material Support)

1. Allergan Healthcare Philippines, Inc.

Contact for Public Queries

Name: Email Address: Phone Number: Postal Address:
Jasmine Tan Acebu Jasmin.Acebu@ppdi.com +632 689 6501 PPD Development Inc., 9th Floor, Sun Life Centre 5th Avenue corner Rizal Drive Bonifacio Global City 1634 Taguig City, Philippines

Contact for Scientific Queries

Name: Email Address: Phone Number: Postal Address:
Barbara Scholz, MD Scholz_Barbara@allergan.com +1 (714) 246 6851 Allergan (North America) 2525 Dupont Drive Irvine, California USA 92612

Investigating Team

Name Expertise Affiliation
Edgar Leuenberger, MD Opthalmologist Asian Eye Institute
Maria Imelda Veloso, MD Opthalmologist Asian Eye Institute
Harvey Uy, MD Opthalmologist Pacific Eye and laser Institute
Benjamin Abela, MD Ophthalmologist Makati Medical Center
Robert Edward T. Ang, MD Opthalmologist Asian Eye Institute
Nilo Vincent de Guzman Florcruz, MD Opthalmologist American Eye Center

Health Condition(s) or Problem(s) Studied

Open Angle Glaucoma or Ocular Hypertension

Primary Outcomes

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 hypertension (OHT) after initial and repeated
administrations

Key Secondary Outcomes

None

Date of First Enrollment

2015-06-01

Recruitment Status

Recruiting

Countries of Recruitment

Philippines

Research Classification

Clinical Trial

Project Location & Institutional Ethics Review Board Which Approved the Study

Project Location Institutional Ethics Review Board
Asian Eye Institute Asian Eye Institute Ethics Review Committee
Pacific Eye and laser Institute St. Luke's Medical Center Institutional Ethics Review Committee
Makati Medical Center Makati Medical Center Institutional Review Board
American Eye Center St. Luke's Medical Center Institutional Ethics Review Committee

FDA Document Tracking Number

20141128164204 , 20141217164313

FDA / ERC Approval Date

2015-04-01

Amendment Approval Dates/Reasons

None

Key Inclusion and Exclusion Criteria (CT)

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
Key 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 Type

Interventional

Intervention Name

Bimatoprost SR

Intervention Description

Patients in the Control group will receive timolol eye drops twice daily (BID) plus Shamadministration in both eyes. Vehicle eye drops will be used BID to mask the treatment of patients receiving Bimatoprost SR in the study eye. Treatment for fellow eyes of patients assigned to 1 of the 2 Bimatoprost SR dose groups will be a Sham administration procedure + timolol eye drops BID.

Method of Allocation

Randomized

Masking / Blinding

Double Blind

Masking Details

Patients and evaluators will be masked to the treatment received.

Assignment

Parallel

Purpose

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 hypertension (OHT) after initial and repeated
administrations

Phase

Phase III

Target Sample Size (Philippines)

12

Actual Sample Size (Philippines)

0

Reason for the difference between target & actual sample sizes

Unspecified

Date of first enrollment

2015-06-01

Research Utilization

None