GlaucomaPhase 3NCT02636946
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing Bimatoprost SR and Selective Laser Trabeculoplasty in people with Glaucoma and Open-Angle Ocular Hypertension, run by Allergan at 33 sites in 9 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle Ocular Hypertension
- What is being tested?
- Bimatoprost SR and Selective Laser Trabeculoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 33 sitesin 9 countries
- Study dates
- 24 Feb 2016to 26 Jan 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.
Who cannot join
- Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
- Enrollment in other studies using Bimatoprost SR.
Trial locations and contacts
33 sites in 9 countries.
33 sites in 9 countries
United States21 sites
Asheville Eye Associates
Asheville, North Carolina, 28803
Emory University Eye Center
Atlanta, Georgia, 30322
Arizona Eye Center
Chandler, Arizona, 85224
Walman Eye Center
Chandler, Arizona, 85225
Eye Associates of Colorado Springs
Colorado Springs, Colorado, 80909
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Eye Center South
Dothan, Alabama, 36301
The Cataract & Glaucoma Center
El Paso, Texas, 79902
Bergstrom Eye Research, LLC
Fargo, North Dakota, 58103
Fraser Eye Center
Fraser, Michigan, 48026
West Coast Eye Institute
Lecanto, Florida, 34461
The Eye Care Institute
Louisville, Kentucky, 40206
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
DCT- Shah Research
Mission, Texas, 78572
Shasta Eye Medical Group, Inc.
Redding, California, 96002
Vistar Eye Center
Roanoke, Virginia, 24016
Coastal Research Associates, LLC
Roswell, Georgia, 30076
San Antonio Eye Center
San Antonio, Texas, 78215
Galanis Cataract and Laser Eye Center
St Louis, Missouri, 63119
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
James D. Branch MD
Winston-Salem, North Carolina, 27101
Poland2 sites
Prywatna Klinika Okulistyczna OFTALMIKA
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631
Centrum Diagnostykii Mikrochirurgii Oka LENS ul.
Olsztyn, Warmian-Masurian Voivodeship, 10-424
Russia2 sites
S. Fyodorov Eye Microsurgery Federal State Institution, Novosibirsk Branch
Novosibirsk, 630071
Ophthalmic Clinical Hospital V.P. Vyhodtseva
Omsk, 644024
Spain2 sites
Centro de Oftalmologia Barraquer
Barcelona, 8021
Hospital Clinico San Carlos
Madrid, 28040
Thailand2 sites
Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital
Chiang Mai, 50200
Thammasat University Hospital
Pathum Thani, 12120
France1 site
CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie
Bordeaux, 33076
About this study
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).
- Conditions
- Glaucoma, Open-Angle Ocular Hypertension
- Being tested
- Bimatoprost SR, Sham Bimatoprost SR, Selective Laser Trabeculoplasty, Sham Selective Laser Trabeculoplasty
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimatoprost SRDrug
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).
Sham Bimatoprost SRDrug
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).
Selective Laser TrabeculoplastyProcedure or surgery
Selective Laser Trabeculoplasty administered on Day 1.
Sham Selective Laser TrabeculoplastyProcedure or surgery
Sham Selective Laser Trabeculoplasty administered on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) | Active comparator | 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. Receives: Drug: Bimatoprost SR; Drug: Sham Bimatoprost SR; Procedure: Selective Laser Trabeculoplasty; Procedure: Sham Selective Laser Trabeculoplasty |
| Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) | Experimental | 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. Receives: Drug: Bimatoprost SR; Drug: Sham Bimatoprost SR; Procedure: Selective Laser Trabeculoplasty; Procedure: Sham Selective Laser Trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP) at Baseline
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (prior to treatment) to Week 24
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start24 Feb 2016
- Primary completion26 Jan 2021
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margot Goodkin, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636946
- Sponsor's protocol ID
- 192024-095
- Other IDs
- 2015-003631-34, 2015
- Status last verified
- Feb 2022
- First submitted
- 10 Dec 2015
- Last updated
- 23 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 35943114
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02636946
- Acronym / sponsor ID
- 192024-095
- Conditions
- Glaucoma, Open-Angle Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 23 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) | Active comparator | Drug: Bimatoprost SR, Drug: Sham Bimatoprost SR, Procedure: Selective Laser Trabeculoplasty, Procedure: Sham Selective Laser TrabeculoplastyPrimary 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. |
| Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) | Experimental | Drug: Bimatoprost SR, Drug: Sham Bimatoprost SR, Procedure: Selective Laser Trabeculoplasty, Procedure: Sham Selective Laser TrabeculoplastyPrimary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.
Key exclusion criteria (2 listed)
- Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
- Enrollment in other studies using Bimatoprost SR.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bimatoprost SRUp 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 | Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye), SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) |
| Sham Bimatoprost SRUp 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). | Drug | Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye), SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) |
| Selective Laser TrabeculoplastySelective Laser Trabeculoplasty administered on Day 1. | Procedure or surgery | Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye), SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) |
| Sham Selective Laser TrabeculoplastySham Selective Laser Trabeculoplasty administered on Day 1. | Procedure or surgery | Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye), SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) |
Primary outcome
Intraocular Pressure (IOP) at Baseline
Time frame: Baseline (prior to treatment)
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
Change From Baseline in IOP at Week 4
Time frame: Baseline (prior to treatment) to 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.
Change From Baseline in IOP at Week 12
Time frame: Baseline (prior to treatment) to 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.
Change From Baseline in Intraocular Pressure (IOP) at Week 24
Time frame: Baseline (prior to treatment) to 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.
3 secondary outcomes
Change From Baseline in IOP at Weeks 8, 15, and 20
Time frame: Baseline (prior to treatment) to Weeks 8, 15 and 20
Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
Time frame: First treatment to end of study (up to 525 days)
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35943114Rolim-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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margot Goodkin study director
Allergan
33 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bimatoprost SR and Selective Laser Trabeculoplasty in people with Glaucoma and Open-Angle Ocular Hypertension, run by Allergan at 33 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Poland, Russia, Spain, Thailand and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (IOP) at Baseline (time frame: Baseline (prior to treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02636946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.