Clinical trial NCT02507687: Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults 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: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-07-24
Enrollment: 240
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 patients 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.
* In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
* In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with SLT monotherapy.

Exclusion Criteria:

* History of previous laser trabeculoplasty
* History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant \[IOL\], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear \[with or without vitreous loss\], substantial iris trauma, etc) or history of phakic IOL insertion for refractive error correction
* Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment
* Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Intraocular Pressure at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Intraocular Pressure at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Time to Initial Use of Non-study IOP-lowering Treatment
timeFrame: From first administration of study treatment to the end of study; overall median follow-up time of 728 days.
measure: Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
timeFrame: Baseline, Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52, Months 13, 14, 15, 16, 18, 20, 22, 24
measure: Change From Baseline in IOP at Weeks 8, 15, and 20
timeFrame: Baseline and Weeks 8, 15, and 20
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trinity Research Group /ID# 234598
state: Alabama
city: Glendale
country: United States
facility: Arizona Advanced Eye Research Institute /ID# 234947
state: Arizona
city: Phoenix
country: United States
facility: Arizona Glaucoma Specialists /ID# 235066
state: Arizona
city: Prescott
country: United States
facility: M&M Eye Institute /ID# 235391
state: Arizona
city: Sun City
country: United States
facility: Walman Eye Center /ID# 236054
state: Arizona
city: Arcadia
country: United States
facility: California Center for Clin Res /ID# 237412
state: California
city: Garden Grove
country: United States
facility: Orange County Ophthalmology /ID# 235995
state: California
city: Glendale
country: United States
facility: Speciality Eye Care Medical Group /ID# 236001
state: California
city: Glendale
country: United States
facility: Lugene Eye Institute /ID# 237042
state: California
city: Irvine
country: United States
facility: Lakeside Vision Center /ID# 234971
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group Inc. /ID# 235999
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates Inc. /ID# 235429
state: California
city: San Francisco
country: United States
facility: Pacific Eye Associates /ID# 235326
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates /ID# 235166
state: California
city: Delray Beach
country: United States
facility: Segal Drug Trials Inc. /ID# 235169
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates of South West Florida /ID# 235424
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates Inc. /ID# 235021
state: Florida
city: Jacksonville
country: United States
facility: University of Florida /ID# 236876
state: Florida
city: Ocala
country: United States
facility: Ocala Eye PA /ID# 235431
state: Florida
city: Tamarac
country: United States
facility: Dr. Andrew Gardner Logan, FL /ID# 236946
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 237737
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC /ID# 236678
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875
state: Illinois
city: Leawood
country: United States
facility: Sabates Eye Centers /ID# 234868
state: Kansas
city: Edgewood
country: United States
facility: Cincinnati Eye Institute- Edgewood /ID# 236714
state: Kentucky
city: Louisville
country: United States
facility: The Eye Care Institute /ID# 236690
state: Kentucky
city: Reading
country: United States
facility: Advanced Glaucoma Specialists /ID# 234799
state: Massachusetts
city: Fraser
country: United States
facility: Fraser Eye Center /ID# 235791
state: Michigan
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879
state: Missouri
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute PA /ID# 234944
state: New Jersey
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico /ID# 235115
state: New Mexico
city: Elizabeth City
country: United States
facility: Albemarle Clinical Trials LLC /ID# 235144
state: North Carolina
city: High Point
country: United States
facility: Duplicate_Cornerstone Eye Care /ID# 235047
state: North Carolina
city: Fargo
country: United States
facility: Bagan Strinden Vision /ID# 234898
state: North Dakota
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons /ID# 235848
state: Oklahoma
city: Cranberry Township
country: United States
facility: Scott and Christie and Associates /ID# 234594
state: Pennsylvania
city: Kingston
country: United States
facility: Eye Care Specialists /ID# 235129
state: Pennsylvania
city: Lancaster
country: United States
facility: Family Eye Group P.C. /ID# 236114
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital /ID# 236487
state: Pennsylvania
city: Florence
country: United States
facility: Carolinas Centers for Sight,PC /ID# 237017
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Eye Institute /ID# 235250
state: Tennessee
city: Austin
country: United States
facility: ATX Clinical Trials Inc. dba Keystone Research /ID# 235869
state: Texas
city: Bellaire
country: United States
facility: Cross Eye Center /ID# 236116
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates /ID# 237883
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Baylor Medical Center /ID# 237148
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center /ID# 235632
state: Texas
city: San Antonio
country: United States
facility: Eye associates /ID# 236501
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates /ID# 235016
state: Texas
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute /ID# 235977
state: Virginia
city: Lynchburg
country: United States
facility: Piedmont Eye Center /ID# 234533
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Eye Institute /ID# 235174
state: West Virginia
city: South Brisbane
country: Australia
facility: Queensland Eye Institute /ID# 236074
state: Queensland
city: East Melbourne
country: Australia
facility: Eye Surgery Associates /ID# 235872
state: Victoria
city: Fitzroy
country: Australia
facility: Melbourne Eye Specialists /ID# 234614
state: Victoria
city: Glen Waverley
country: Australia
facility: Waverley Eye Clinic /ID# 234997
state: Victoria
city: Nedlands
country: Australia
facility: The Lions Eye Institute /ID# 236832
state: Western Australia
city: Essendon
country: Australia
facility: Essendon Eye Clinic /ID# 235433
city: Geelong
country: Australia
facility: Geelong Eye Clinic /ID# 236118
city: Melbourne
country: Australia
facility: Vision Eye Institute /ID# 236003
city: Montreal
country: Canada
facility: Ophthalmology Clinic Bellevue /ID# 234631
state: Quebec
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup /ID# 237709
state: Hovedstaden
city: Angers
country: France
facility: Chu Angers /Id# 237805
city: Avranches
country: France
facility: Polyclinique de la Baie /ID# 235842
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Pellegrin /ID# 237705
city: Montauban
country: France
facility: Clinique Honore Cave - Pharmacie /ID# 235925
city: Nice
country: France
facility: CHU de Nice - Hospital Pasteur 2 /ID# 235844
city: Strasbourg cedex
country: France
facility: CHU Strasbourg - Hopital Civil /ID# 237837
city: Toulouse
country: France
facility: Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841
city: Dusseldorf
country: Germany
facility: Internationale Innovative Ophthalmochirurgie /ID# 235263
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg /ID# 237284
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 237211
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 237741
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center /ID# 236757
city: Nahariya
country: Israel
facility: Galilee Medical Center /ID# 235742
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 237698
city: Remuera
country: New Zealand
facility: Auckland Eye Hospital /ID# 235253
state: Auckland
city: Christchurch
country: New Zealand
facility: Southern Eye Specialists /ID# 236081
state: Canterbury
city: Wellington
country: New Zealand
facility: Capital Eye Specialists /ID# 236111
city: Makati City
country: Philippines
facility: Asian Eye Institute /ID# 235092
city: Makati City
country: Philippines
facility: Peregrine Eye and Laser Institute /ID# 236220
city: Makati City
country: Philippines
facility: American Eye Center /ID# 235320
city: San Juan City
country: Philippines
facility: Cardinal Santos Medical Center /ID# 235325
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 235929
city: Omsk
country: Russian Federation
facility: Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041
city: Samara
country: Russian Federation
facility: Samara State Medical University /ID# 236997
city: Derby
country: United Kingdom
facility: University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129
state: Derbyshire
city: Greater London
country: United Kingdom
facility: Queen Mary's Hospital /ID# 234899
state: Kent
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 236806
state: London, City Of
city: Carshalton
country: United Kingdom
facility: Epsom & St Helier University Hospital NHS Trust /ID# 236902
state: Surrey
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust /ID# 238315
city: Edinburgh
country: United Kingdom
facility: NHS Lothian /ID# 237450
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust /ID# 237708
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust /ID# 234777
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust /ID# 237318
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
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.