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

Sponsor

AbbVie (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02507687

Collaborator

(none)

215

Enrollment

Locations

Arms

92.9

Anticipated Duration (Months)

2.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the intraocular pressure-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.

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

Anticipated Enrollment :

215 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, 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 :

Aug 27, 2015

Anticipated Primary Completion Date :

May 24, 2023

Anticipated Study Completion Date :

May 24, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimatoprost Sustained-Release (SR) Assigned Primary Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).	Drug: Bimatoprost SR Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Drug: Sham Bimatoprost SR Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Procedure: Selective Laser Trabeculoplasty Selective Laser Trabeculoplasty administered on Day 1. Procedure: Sham Selective Laser Trabeculoplasty Sham Selective Laser Trabeculoplasty administered on Day 1.
Active Comparator: Selective Laser Trabeculoplasty (SLT) Assigned Primary Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).	Drug: Bimatoprost SR Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Drug: Sham Bimatoprost SR Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Procedure: Selective Laser Trabeculoplasty Selective Laser Trabeculoplasty administered on Day 1. Procedure: Sham Selective Laser Trabeculoplasty Sham Selective Laser Trabeculoplasty administered on Day 1.

Arm

Intervention/Treatment

Experimental: Bimatoprost Sustained-Release (SR)

Assigned Primary Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

Drug: Bimatoprost SR

Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

Drug: Sham Bimatoprost SR

Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

Procedure: Selective Laser Trabeculoplasty

Selective Laser Trabeculoplasty administered on Day 1.

Procedure: Sham Selective Laser Trabeculoplasty

Sham Selective Laser Trabeculoplasty administered on Day 1.

Active Comparator: Selective Laser Trabeculoplasty (SLT)

Assigned Primary Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

Drug: Bimatoprost SR

Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

Drug: Sham Bimatoprost SR

Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

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

Change from Baseline in IOP at Week 4 [Baseline, Week 4]
Change from Baseline in IOP at Week 12 [Baseline, Week 12]
Change from Baseline in Intraocular Pressure (IOP) at Week 24 [Baseline, Week 24]

Secondary Outcome Measures

IOP change from baseline at Week 8 [Baseline, Week 8]
IOP change from baseline at Week 15 [Baseline, Week 15]
IOP change from baseline at Week 20 [Baseline, Week 20]
Time to initial use of nonstudy IOP-lowering treatment as determined by the investigator [Baseline, Month 24]
Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 4 [Baseline, Week 4]
Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 12 [Baseline, Week 12]
Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 24 [Baseline, Week 24]
Percentage of SLT eyes achieving ≥ 20% reduction at Week 4 [Baseline, Week 4]
Percentage of SLT eyes achieving ≥ 20% reduction at Week 12 [Baseline, Week 12]
Percentage of SLT eyes achieving ≥ 20% reduction at Week 24 [Baseline, Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
Previous use of commercially available Bimatoprost SR; c oncurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trinity Research Group /ID# 234598	Dothan	Alabama	United States	36301
2	Arizona Advanced Eye Research Institute /ID# 234947	Glendale	Arizona	United States	85306
3	M&M Eye Institute /ID# 235391	Prescott	Arizona	United States	86301
4	Walman Eye Center /ID# 236054	Sun City	Arizona	United States	85351
5	California Center for Clin Res /ID# 237412	Arcadia	California	United States	91007
6	Orange County Ophthalmology /ID# 235995	Garden Grove	California	United States	92843
7	Speciality Eye Care Medical Group /ID# 236001	Glendale	California	United States	91203
8	Lugene Eye Institute /ID# 237042	Glendale	California	United States	91204
9	Lakeside Vision Center /ID# 234971	Irvine	California	United States	92604
10	California Eye Specialists Medical Group Inc. /ID# 235999	Pasadena	California	United States	91107
11	Pacific Eye Associates /ID# 235326	San Francisco	California	United States	94115
12	Wolstan & Goldberg Eye Associates /ID# 235166	Torrance	California	United States	90505
13	Segal Drug Trials Inc. /ID# 235169	Delray Beach	Florida	United States	33484
14	Duplicate_Eye Associates of South West Florida /ID# 235424	Fort Myers	Florida	United States	33901-9311
15	Levenson Eye Associates Inc. /ID# 235021	Jacksonville	Florida	United States	32204
16	University of Florida /ID# 236876	Jacksonville	Florida	United States	32209
17	Ocala Eye PA /ID# 235431	Ocala	Florida	United States	34474
18	Dr. Andrew Gardner Logan, FL /ID# 236946	Tamarac	Florida	United States	33321
19	University of South Florida /ID# 237737	Tampa	Florida	United States	33612
20	Clayton Eye Clinical Research, LLC /ID# 236678	Morrow	Georgia	United States	30260-4180
21	University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875	Chicago	Illinois	United States	60612
22	Sabates Eye Centers /ID# 234868	Leawood	Kansas	United States	66211
23	Cincinnati Eye Institute- Edgewood /ID# 236714	Edgewood	Kentucky	United States	41017-3415
24	The Eye Care Institute /ID# 236690	Louisville	Kentucky	United States	40206-1738
25	Advanced Glaucoma Specialists /ID# 234799	Reading	Massachusetts	United States	01867
26	Fraser Eye Center /ID# 235791	Fraser	Michigan	United States	48026
27	Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879	Chesterfield	Missouri	United States	63017
28	Northern New Jersey Eye Institute PA /ID# 234944	South Orange	New Jersey	United States	07079-1855
29	Eye Associates of New Mexico /ID# 235115	Albuquerque	New Mexico	United States	87109
30	Albemarle Clinical Trials LLC /ID# 235144	Elizabeth City	North Carolina	United States	27909
31	Duplicate_Cornerstone Eye Care /ID# 235047	High Point	North Carolina	United States	27262
32	Bagan Strinden Vision /ID# 234898	Fargo	North Dakota	United States	58103
33	Oklahoma Eye Surgeons /ID# 235848	Oklahoma City	Oklahoma	United States	73112
34	Scott and Christie and Associates /ID# 234594	Cranberry Township	Pennsylvania	United States	16066
35	Eye Care Specialists /ID# 235129	Kingston	Pennsylvania	United States	18704
36	Family Eye Group P.C. /ID# 236114	Lancaster	Pennsylvania	United States	17601-2644
37	Wills Eye Hospital /ID# 236487	Philadelphia	Pennsylvania	United States	19107
38	Carolinas Centers for Sight,PC /ID# 237017	Florence	South Carolina	United States	29501
39	Chattanooga Eye Institute /ID# 235250	Chattanooga	Tennessee	United States	37411
40	ATX Clinical Trials Inc. dba Keystone Research /ID# 235869	Austin	Texas	United States	78731
41	Cross Eye Center /ID# 236116	Bellaire	Texas	United States	77401
42	Houston Eye Associates /ID# 237883	Houston	Texas	United States	77025
43	Baylor College of Medicine - Baylor Medical Center /ID# 237148	Houston	Texas	United States	77030-3411
44	San Antonio Eye Center /ID# 235632	San Antonio	Texas	United States	78215
45	Emerson Clinical Research Institute /ID# 235977	Falls Church	Virginia	United States	22046
46	Piedmont Eye Center /ID# 234533	Lynchburg	Virginia	United States	24502
47	West Virginia University Eye Institute /ID# 235174	Morgantown	West Virginia	United States	26501
48	Queensland Eye Institute /ID# 236074	South Brisbane	Queensland	Australia	4101
49	Eye Surgery Associates /ID# 235872	East Melbourne	Victoria	Australia	3002
50	Melbourne Eye Specialists /ID# 234614	Fitzroy	Victoria	Australia	VIC3065
51	Waverley Eye Clinic /ID# 234997	Glen Waverley	Victoria	Australia	3150
52	The Lions Eye Institute /ID# 236832	Nedlands	Western Australia	Australia	6009
53	Essendon Eye Clinic /ID# 235433	Essendon		Australia	3040
54	Geelong Eye Clinic /ID# 236118	Geelong		Australia	3220
55	Vision Eye Institute /ID# 236003	Melbourne		Australia	3058
56	Ophthalmology Clinic Bellevue /ID# 234631	Montreal	Quebec	Canada	H1V 1G5
57	Rigshospitalet Glostrup /ID# 237709	Glostrup	Hovedstaden	Denmark	2600
58	Chu Angers /Id# 237805	Angers		France	49933
59	Polyclinique de la Baie /ID# 235842	Avranches		France	50300
60	CHU Bordeaux - Hopital Pellegrin /ID# 237705	Bordeaux		France	33000
61	Clinique Honore Cave - Pharmacie /ID# 235925	Montauban		France	82000
62	CHU de Nice - Hospital Pasteur 2 /ID# 235844	Nice		France	06000
63	CHU Strasbourg - Hopital Civil /ID# 237837	Strasbourg cedex		France	67091
64	Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841	Toulouse		France	31000
65	Universitaetsklinikum Magdeburg /ID# 237284	Magdeburg		Germany	39120
66	Tel Aviv Sourasky Medical Center /ID# 237211	Tel Aviv-Yafo	Tel-Aviv	Israel	6423906
67	Rambam Health Care Campus /ID# 237741	Haifa		Israel	3109601
68	The Lady Davis Carmel Medical Center /ID# 236757	Haifa		Israel	34362
69	Galilee Medical Center /ID# 235742	Naharia		Israel	2210001
70	Rabin Medical Center /ID# 237698	Petakh Tikva		Israel	4941492
71	Auckland Eye Hospital /ID# 235253	Remuera	Auckland	New Zealand	1050
72	Southern Eye Specialists /ID# 236081	Christchurch	Canterbury	New Zealand	8013
73	Capital Eye Specialists /ID# 236111	Wellington		New Zealand	6011
74	Asian Eye Institute /ID# 235092	Makati City		Philippines	1200
75	Peregrine Eye and Laser Institute /ID# 236220	Makati City		Philippines	1209
76	American Eye Center /ID# 235320	Makati City		Philippines	1229
77	Cardinal Santos Medical Center /ID# 235325	San Juan City		Philippines	1502
78	Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 235929	Olsztyn		Poland	10-424
79	Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041	Omsk		Russian Federation	644024
80	Samara State Medical University /ID# 236997	Samara		Russian Federation	443099
81	University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129	Derby	Derbyshire	United Kingdom	DE22 3NE
82	Queen Mary's Hospital /ID# 234899	Greater London	Kent	United Kingdom	DA14 6LT
83	Guy's and St Thomas' NHS Foundation Trust /ID# 236806	London	London, City Of	United Kingdom	SE1 9RT
84	Epsom & St Helier University Hospital NHS Trust /ID# 236902	Carshalton	Surrey	United Kingdom	SM5 1AA
85	Cambridge University Hospitals NHS Foundation Trust /ID# 238315	Cambridge		United Kingdom	CB2 0QQ
86	NHS Lothian /ID# 237450	Edinburgh		United Kingdom	EH3 9HE
87	Moorfields Eye Hospital NHS Foundation Trust /ID# 237708	London		United Kingdom	EC1V 2PD
88	Imperial College Healthcare NHS Trust /ID# 234777	London		United Kingdom	W2 1NY
89	Manchester University NHS Foundation Trust /ID# 237318	Manchester		United Kingdom	M13 9WL

Sponsors and Collaborators

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@allergan.com for assistance.

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT02507687

Other Study ID Numbers:

192024-093
2015-002131-18

First Posted:

Jul 24, 2015

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 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:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022