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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02636946
• Collaborator: (none)
• Enrollment: 144
• Locations: 33
• Arms: 2
• Actual Duration (Months): 59.1
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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 efficacy (e.g., due to intolerance or nonadherence).

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Open-Angle Ocular Hypertension	Drug: Bimatoprost SR; Drug: Sham Bimatoprost SR; Procedure: Selective Laser Trabeculoplasty; Procedure: Sham Selective Laser Trabeculoplasty	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
• Actual Study Start Date: Feb 24, 2016
• Actual Primary Completion Date: Jan 26, 2021
• Actual Study Completion Date: Jan 26, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure (IOP) at Baseline [Baseline (prior to treatment)]

   IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.

2. Change From Baseline in IOP at Week 4 [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.

3. Change From Baseline in IOP at Week 12 [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.

4. Change From Baseline in Intraocular Pressure (IOP) at Week 24 [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.

Secondary Outcome Measures

1. Change From Baseline in IOP at Weeks 8, 15, and 20 [Baseline (prior to treatment) to 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.

2. Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator [First treatment to end of study (up to 525 days)]

   Median time in days from first treatment to the initial use of non-study IOP-lowering treatment.

3. Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP [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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Margot Goodkin, Allergan

Study Documents (Full-Text)

• Study Protocol - Mar 27, 2020
• Statistical Analysis Plan - Oct 2, 2020

More Information

Additional Information:

• clinical study report synopsis

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02636946
• Other Study ID Numbers: 192024-095; 2015-003631-34
• First Posted: Dec 22, 2015
• Last Update Posted: Feb 23, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Bimatoprost

Study Results

Participant Flow

Pre-assignment Detail	A total of 144 participants were randomized with 72 participants in each treatment group. Out of them 142 participants were treated. The primary eye was defined as the eye with the higher intraocular pressure (IOP) at Baseline. If both the eyes were the same, the right eye was used as the primary eye. The contralateral eye is the other eye.

Arm/Group Title	SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)	Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
Arm/Group Description	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.	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.
Period Title: Cycle 1 (Day 1 to Week 15)
STARTED	72	72
Received Treatment in Either Eye	72	70
COMPLETED	71	67
NOT COMPLETED	1	5
Period Title: Cycle 1 (Day 1 to Week 15)
STARTED	65	62
COMPLETED	63	61
NOT COMPLETED	2	1
Period Title: Cycle 1 (Day 1 to Week 15)
STARTED	17	16
COMPLETED	17	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)	Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	72	72	144
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.9 (10.2)	62.1 (11.4)	60.0 (11.0)
Sex: Female, Male (Count of Participants)
Female	28 38.9%	39 54.2%	67 46.5%
Male	44 61.1%	33 45.8%	77 53.5%
Race/Ethnicity, Customized (Count of Participants)
White	53 73.6%	59 81.9%	112 77.8%
Black or African American	12 16.7%	9 12.5%	21 14.6%
Asian	5 6.9%	3 4.2%	8 5.6%
Not Reported	2 2.8%	1 1.4%	3 2.1%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	11 15.3%	7 9.7%	18 12.5%
Non-Hispanic	61 84.7%	64 88.9%	125 86.8%
Not Reported	0 0%	1 1.4%	1 0.7%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure (IOP) at Baseline
Description	IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
Time Frame	Baseline (prior to treatment)

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT) Population was defined based in the Intent-to-Treat (ITT) population but excluded participants who did not receive the second implant after implementation of Amendment 3.

Arm/Group Title	Selective Laser Trabeculoplasty	Bim SR 15 μg
Arm/Group Description	SLT administered on Day 1. Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.	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. Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
Measure Participants	138	138
Mean (Standard Deviation) [millimeters of mercury (mmHg)]	24.45 (2.75)	24.38 (2.49)

2. Primary Outcome

Title	Change From Baseline in IOP at Week 4
Description	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.
Time Frame	Baseline (prior to treatment) to Week 4

Outcome Measure Data

Analysis Population Description

mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses.

Arm/Group Title	Selective Laser Trabeculoplasty	Bim SR 15 μg
Arm/Group Description	SLT administered on Day 1. Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.	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. Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
Measure Participants	131	135
Measure eyes	131	135
Least Squares Mean (Standard Error) [mmHg]	-6.28 (0.30)	-6.98 (0.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selective Laser Trabeculoplasty, Bim SR 15 μg
	Comments	Change from Baseline at Week 4: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).
	Type of Statistical Test	Non-Inferiority
	Comments	MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.
Statistical Test of Hypothesis	p-Value	0.0166
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	Least-squares Mean Difference
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -1.28 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

3. Primary Outcome

Title	Change From Baseline in IOP at Week 12
Description	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.
Time Frame	Baseline (prior to treatment) to Week 12

Outcome Measure Data

Analysis Population Description

mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses.

Arm/Group Title	Selective Laser Trabeculoplasty	Bim SR 15 μg
Arm/Group Description	SLT administered on Day 1. Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.	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. Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
Measure Participants	122	128
Measure eyes	122	128
Least Squares Mean (Standard Error) [mmHg]	-6.28 (0.29)	-6.81 (0.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selective Laser Trabeculoplasty, Bim SR 15 μg
	Comments	Change from Baseline at Week 12: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).
	Type of Statistical Test	Non-Inferiority
	Comments	MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.
Statistical Test of Hypothesis	p-Value	0.0735
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	Least-squares Mean Difference
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95%; -1.09 to 0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

4. Primary Outcome

Title	Change From Baseline in Intraocular Pressure (IOP) at Week 24
Description	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.
Time Frame	Baseline (prior to treatment) to Week 24

Outcome Measure Data

Analysis Population Description

mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses.

Arm/Group Title	Selective Laser Trabeculoplasty	Bim SR 15 μg
Arm/Group Description	SLT administered on Day 1. Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.	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. Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
Measure Participants	117	126
Measure eyes	117	126
Least Squares Mean (Standard Error) [mmHg]	-6.34 (0.29)	-6.59 (0.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selective Laser Trabeculoplasty, Bim SR 15 μg
	Comments	Change from Baseline at Week 24: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% confidence interval (CI) was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).
	Type of Statistical Test	Non-Inferiority
	Comments	MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.
Statistical Test of Hypothesis	p-Value	0.3928
	Comments
	Method	MMRM
	Comments
Method of Estimation	Estimation Parameter	Least-squares Mean Difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -0.81 to 0.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline in IOP at Weeks 8, 15, and 20
Description	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.
Time Frame	Baseline (prior to treatment) to Weeks 8, 15 and 20

Outcome Measure Data

Analysis Population Description

ITT Population was defined as all randomized participants. Number analyzed is the number of participants and eyes analyzed at the given timepoint.

Arm/Group Title	Selective Laser Trabeculoplasty	Bim SR 15 μg
Arm/Group Description	SLT administered on Day 1. Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.	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. Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
Measure Participants	144	144
Measure eyes	144	144
Change from Baseline at Week 8	-6.65 (3.10)	-7.09 (2.93)
Change from Baseline at Week 15	-6.14 (3.47)	-5.36 (3.73)
Change from Baseline at Week 20	-5.06 (3.33)	-4.29 (1.93)

6. Secondary Outcome

Title	Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
Description	Median time in days from first treatment to the initial use of non-study IOP-lowering treatment.
Time Frame	First treatment to end of study (up to 525 days)

Outcome Measure Data

Analysis Population Description

ITT Population was defined as all randomized participants. Overall number analyzed are number of participants and eyes with data available for analyses.

Arm/Group Title	Selective Laser Trabeculoplasty	Bim SR 15 μg
Arm/Group Description	SLT administered on Day 1. Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.	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. Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
Measure Participants	142	141
Measure eyes	142	141
Median (95% Confidence Interval) [days]	410	446

7. Secondary Outcome

Title	Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Description	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.
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

Outcome Measure Data

Analysis Population Description

ITT Population was defined as all randomized participants. Number analyzed is number of participants and eyes analyzed at the given timepoint.

Arm/Group Title	Selective Laser Trabeculoplasty	Bim SR 15 μg
Arm/Group Description	SLT administered on Day 1. Participants' primary eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and contralateral eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.	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. Participants' contralateral eyes from 'SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)' arm and primary eyes from 'Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)' arm were combined for outcome measure analyses.
Measure Participants	144	144
Measure eyes	144	144
Cycle 1 Day 2	60.6 84.2%	92.7 128.8%
Cycle 1 Week 4	70.2 97.5%	78.0 108.3%
Cycle 1 Week 8	72.9 101.3%	80.0 111.1%
Cycle 1 Week 12	67.9 94.3%	75.2 104.4%
Cycle 1 Week 15	67.2 93.3%	64.2 89.2%
Cycle 1 Week 20	50.0 69.4%	40.0 55.6%
Cycle 1 Week 24	81.8 113.6%	45.5 63.2%
Cycle 1 Week 28	63.6 88.3%	45.5 63.2%
Cycle 1 Week 31	100.0 138.9%	40.0 55.6%
Cycle 1 Week 36	72.7 101%	72.7 101%
Cycle 1 Week 40	54.5 75.7%	54.5 75.7%
Cycle 1 Week 44	81.8 113.6%	45.5 63.2%
Cycle 1 Week 47	72.7 101%	54.5 75.7%
Cycle 1 Week 52	81.8 113.6%	81.8 113.6%
Cycle 2 Day 2	70.2 97.5%	89.5 124.3%
Cycle 2 Week 4	68.8 95.6%	75.2 104.4%
Cycle 2 Week 8	68.5 95.1%	71.0 98.6%
Cycle 2 Week 12	72.0 100%	65.3 90.7%
Cycle 2 Week 15	69.4 96.4%	64.3 89.3%
Cycle 2 Week 20	76.9 106.8%	64.8 90%
Cycle 2 Week 24	64.4 89.4%	71.3 99%
Cycle 2 Week 28	76.5 106.3%	74.1 102.9%
Cycle 2 Week 31	76.7 106.5%	74.4 103.3%
Cycle 2 Week 36	79.1 109.9%	67.0 93.1%
Cycle 3 Day 2	75.8 105.3%	90.9 126.3%
Cycle 3 Week 4	74.2 103.1%	71.0 98.6%
Cycle 3 Week 8	75.0 104.2%	59.4 82.5%
Cycle 3 Week 15	70.0 97.2%	43.3 60.1%
Cycle 3 Week 20	69.7 96.8%	39.4 54.7%

Adverse Events

Time Frame	First treatment to end of study (up to 525 days)
Adverse Event Reporting Description	All-cause Mortality: ITT Population included all randomized participants. Serious and Other AEs: Safety Population included all participants who received treatment and data is collected and presented as per randomization. Ocular AEs reported for Eye Disorders were collected for each eye (primary eye or contralateral eye) separately. The AE footnotes are used to report the number of AEs that occurred in the primary eye and in the contralateral eye. A participant could have ≥1 events.
Arm/Group Title	SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)		Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
Arm/Group Description	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.		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.
All Cause Mortality
	SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)		Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/72 (0%)
Serious Adverse Events
	SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)		Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/72 (15.3%)		6/70 (8.6%)
Cardiac disorders
Myocardial infarction	1/72 (1.4%)		0/70 (0%)
Eye disorders
Corneal endothelial cell loss	4/72 (5.6%)		1/70 (1.4%)
Cataract	1/72 (1.4%)		0/70 (0%)
Corneal oedema	0/72 (0%)		2/70 (2.9%)
Immune system disorders
Drug hypersensitivity	1/72 (1.4%)		0/70 (0%)
Infections and infestations
COVID-19 pneumonia	1/72 (1.4%)		0/70 (0%)
Injury, poisoning and procedural complications
Alcohol poisoning	1/72 (1.4%)		0/70 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/72 (1.4%)		0/70 (0%)
Lung neoplasm malignant	1/72 (1.4%)		0/70 (0%)
Pancreatic carcinoma	1/72 (1.4%)		0/70 (0%)
Nervous system disorders
Quadrantanopia	1/72 (1.4%)		0/70 (0%)
Dizziness	0/72 (0%)		1/70 (1.4%)
Renal and urinary disorders
Acute kidney injury	0/72 (0%)		1/70 (1.4%)
Nephrolithiasis	0/72 (0%)		1/70 (1.4%)
Renal haematoma	0/72 (0%)		1/70 (1.4%)
Renal haemorrhage	0/72 (0%)		1/70 (1.4%)
Ureteric stenosis	0/72 (0%)		1/70 (1.4%)
Ureterolithiasis	0/72 (0%)		1/70 (1.4%)
Other (Not Including Serious) Adverse Events
	SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)		Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	56/72 (77.8%)		44/70 (62.9%)
Eye disorders
Conjunctival hyperaemia	30/72 (41.7%)		19/70 (27.1%)
Corneal endothelial cell loss	11/72 (15.3%)		4/70 (5.7%)
Punctate keratitis	10/72 (13.9%)		8/70 (11.4%)
Conjunctival haemorrhage	7/72 (9.7%)		5/70 (7.1%)
Corneal oedema	6/72 (8.3%)		9/70 (12.9%)
Photophobia	6/72 (8.3%)		4/70 (5.7%)
Eye irritation	6/72 (8.3%)		3/70 (4.3%)
Eye pain	5/72 (6.9%)		9/70 (12.9%)
Dry eye	5/72 (6.9%)		3/70 (4.3%)
Anterior chamber cell	4/72 (5.6%)		3/70 (4.3%)
Foreign body sensation in eyes	4/72 (5.6%)		3/70 (4.3%)
Corneal opacity	4/72 (5.6%)		0/70 (0%)
Infections and infestations
Conjunctivitis	4/72 (5.6%)		1/70 (1.4%)
Sinusitis	1/72 (1.4%)		4/70 (5.7%)
Investigations
Intraocular pressure increased	13/72 (18.1%)		7/70 (10%)
Metabolism and nutrition disorders
Type 2 diabetes mellitus	0/72 (0%)		4/70 (5.7%)
Nervous system disorders
Headache	3/72 (4.2%)		4/70 (5.7%)
Vascular disorders
Hypertension	2/72 (2.8%)		6/70 (8.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.