Clinical trial NCT02636946: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Open-Angle Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular Pressure (IOP) at Baseline
timeFrame: Baseline (prior to treatment)
measure: Change From Baseline in IOP at Week 4
timeFrame: Baseline (prior to treatment) to Week 4
measure: Change From Baseline in IOP at Week 12
timeFrame: Baseline (prior to treatment) to Week 12
measure: Change From Baseline in Intraocular Pressure (IOP) at Week 24
timeFrame: Baseline (prior to treatment) to Week 24
Secondary outcomes:
measure: Change From Baseline in IOP at Weeks 8, 15, and 20
timeFrame: Baseline (prior to treatment) to Weeks 8, 15 and 20
measure: Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
timeFrame: First treatment to end of study (up to 525 days)
measure: Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
timeFrame: 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
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Eye Center South
state: Alabama
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Chandler
country: United States
facility: Walman Eye Center
state: Arizona
city: Redding
country: United States
facility: Shasta Eye Medical Group, Inc.
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Colorado Springs
country: United States
facility: Eye Associates of Colorado Springs
state: Colorado
city: Lecanto
country: United States
facility: West Coast Eye Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Eye Center
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Fraser
country: United States
facility: Fraser Eye Center
state: Michigan
city: Saint Louis
country: United States
facility: Galanis Cataract and Laser Eye Center
state: Missouri
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: James D. Branch MD
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye Research, LLC
state: North Dakota
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: El Paso
country: United States
facility: The Cataract & Glaucoma Center
state: Texas
city: Mission
country: United States
facility: DCT- Shah Research
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: Roanoke
country: United States
facility: Vistar Eye Center
state: Virginia
city: Parramatta
country: Australia
facility: Marsden Eye Specialists
state: New South Wales
city: Glostrup
country: Denmark
facility: Glostrup Hospital
state: Hovedstaden
city: Bordeaux
country: France
facility: CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie
city: Bydgoszcz
country: Poland
facility: Prywatna Klinika Okulistyczna OFTALMIKA
state: Kuyavian-Pomeranian Voivodeship
city: Olsztyn
country: Poland
facility: Centrum Diagnostykii Mikrochirurgii Oka LENS ul.
state: Warmian-Masurian Voivodeship
city: Novosibirsk
country: Russian Federation
facility: S. Fyodorov Eye Microsurgery Federal State Institution, Novosibirsk Branch
city: Omsk
country: Russian Federation
facility: Ophthalmic Clinical Hospital V.P. Vyhodtseva
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
city: Barcelona
country: Spain
facility: Centro de Oftalmologia Barraquer
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Chiang Mai
country: Thailand
facility: Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital
city: Pathumthani
country: Thailand
facility: Thammasat University Hospital
Study officials:
affiliation: Allergan
name: Margot Goodkin
role: STUDY_DIRECTOR
References:
citation: 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.