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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636946
• Other study ID #: 192024-095
• Secondary ID: 2015-003631-34
• Status: Completed
• Phase: Phase 3
• Start date: February 24, 2016
• Est. completion date: January 26, 2021

Study information

• Verified date: February 2022
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 26, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Ocular Hypertension

Intervention

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).
• 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.
• Sham Selective Laser Trabeculoplasty
Sham Selective Laser Trabeculoplasty administered on Day 1.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  France,  Poland,  Russian Federation,  Singapore,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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	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
Secondary	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)
Secondary	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

External Links

•   clinical study report synopsis