Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension 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: NCT02507687
• Other study ID #: 192024-093
• Secondary ID: 2015-002131-18
• Status: Completed
• Phase: Phase 3
• Start date: August 27, 2015
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2024
• Source: AbbVie
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 31, 2023
• Est. primary completion date: November 24, 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.
• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bimatoprost SR
Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.
• Sham Bimatoprost SR
Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.

Procedure:
• Selective Laser Trabeculoplasty
SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye. An ophthalmologist performed 360 degrees of SLT using a standardized method.
• Sham Selective Laser Trabeculoplasty
Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  France,  Germany,  Israel,  New Zealand,  Philippines,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Intraocular Pressure at Week 4	Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. A mixed-effects model with repeated measures (MMRM) was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.	Baseline and Week 4
Primary	Change From Baseline in Intraocular Pressure at Week 12	Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.	Baseline and Week 12
Primary	Change From Baseline in Intraocular Pressure at Week 24	Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.	Baseline and Week 24
Secondary	Time to Initial Use of Non-study IOP-lowering Treatment	The time from the date of initial treatment to the date date of first use of non-study IOP-lowering treatment (rescue) was analyzed using the Kaplan-Meier method.; If a participant did not use any non-study IOP-lowering treatment in an eye, then the event (initial use of non-study IOP-lowering treatment) time was censored at the study exit date or the last visit date if the study exit date was not available.	From first administration of study treatment to the end of study; overall median follow-up time of 728 days.
Secondary	Percentage of Eyes Achieving = 20% Reduction in IOP From Baseline Regardless of Cycle	Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer.; For by-cycle analyses, cycle number refers to the administration cycle for bimatoprost SR, or sham bimatoprost SR administration in SLT-treated eyes. For SLT-treated eyes cycle number does not refer to SLT administrations, because SLT was only performed once (Day 1). The Day/Week number refers to the number of days/weeks after bimatoprost SR/sham bimatoprost SR administration.; IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.	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
Secondary	Change From Baseline in IOP at Weeks 8, 15, and 20	IOP was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.	Baseline and Weeks 8, 15, and 20

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