A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).

Study Overview

• Status: Completed
• Conditions: Glaucoma; Open-Angle Ocular Hypertension
• Intervention / Treatment: Drug: Bimatoprost SR; Drug: Sham Bimatoprost SR; Procedure: Selective Laser Trabeculoplasty; Procedure: Sham Selective Laser Trabeculoplasty

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Parramatta, New South Wales, Australia, 2150
      • Marsden Eye Specialists
• Denmark
  • Hovedstaden
    • Glostrup, Hovedstaden, Denmark, 2600
      • Glostrup Hospital
• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-631
      • Prywatna Klinika Okulistyczna OFTALMIKA
  • Warmian-Masurian Voivodeship
    • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-424
      • Centrum Diagnostykii Mikrochirurgii Oka LENS ul.
• Russian Federation
  • Novosibirsk, Russian Federation, 630071
    • S. Fyodorov Eye Microsurgery Federal State Institution, Novosibirsk Branch
  • Omsk, Russian Federation, 644024
    • Ophthalmic Clinical Hospital V.P. Vyhodtseva
• Singapore
  • Singapore, Singapore, 168751
    • Singapore National Eye Centre
• Spain
  • Barcelona, Spain, 8021
    • Centro de Oftalmologia Barraquer
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
• Thailand
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital
  • Pathumthani, Thailand, 12120
    • Thammasat University Hospital
• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Eye Center South
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Eye Center
    • Chandler, Arizona, United States, 85225
      • Walman Eye Center
  • California
    • Redding, California, United States, 96002
      • Shasta Eye Medical Group, Inc.
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Eye Associates of Colorado Springs
  • Florida
    • Lecanto, Florida, United States, 34461
      • West Coast Eye Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Eye Center
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Institute
  • Michigan
    • Fraser, Michigan, United States, 48026
      • Fraser Eye Center
  • Missouri
    • Saint Louis, Missouri, United States, 63119
      • Galanis Cataract and Laser Eye Center
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Eye Associates
    • Winston-Salem, North Carolina, United States, 27101
      • James D. Branch MD
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Bergstrom Eye Research, LLC
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
  • Texas
    • El Paso, Texas, United States, 79902
      • The Cataract & Glaucoma Center
    • Mission, Texas, United States, 78572
      • DCT- Shah Research
    • San Antonio, Texas, United States, 78215
      • San Antonio Eye Center
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Vistar Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.

Exclusion Criteria:

• Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
• Enrollment in other studies using Bimatoprost SR.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye); Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.	Drug: Bimatoprost SR; Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).; Drug: Sham Bimatoprost SR; Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).; Procedure: Selective Laser Trabeculoplasty; Selective Laser Trabeculoplasty administered on Day 1.; Procedure: Sham Selective Laser Trabeculoplasty; Sham Selective Laser Trabeculoplasty administered on Day 1.
Experimental: Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye); Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.	Drug: Bimatoprost SR; Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).; Drug: Sham Bimatoprost SR; Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).; Procedure: Selective Laser Trabeculoplasty; Selective Laser Trabeculoplasty administered on Day 1.; Procedure: Sham Selective Laser Trabeculoplasty; Sham Selective Laser Trabeculoplasty administered on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP) at Baseline	IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.	Baseline (prior to treatment)
Change From Baseline in IOP at Week 4	IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses.	Baseline (prior to treatment) to Week 4
Change From Baseline in IOP at Week 12	IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.	Baseline (prior to treatment) to Week 12
Change From Baseline in Intraocular Pressure (IOP) at Week 24	IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.	Baseline (prior to treatment) to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in IOP at Weeks 8, 15, and 20	IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.	Baseline (prior to treatment) to Weeks 8, 15 and 20
Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator	Median time in days from first treatment to the initial use of non-study IOP-lowering treatment.	First treatment to end of study (up to 525 days)
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP	IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3.	Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Margot Goodkin, Allergan

Publications and helpful links

General Publications

• Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2016
• Primary Completion (Actual): January 26, 2021
• Study Completion (Actual): January 26, 2021

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: 192024-095; 2015-003631-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No