Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03850782

Collaborator

(none)

490

Enrollment

113

Locations

Arms

Anticipated Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: Bimatoprost (SR)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

490 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Actual Study Start Date :

Feb 28, 2019

Anticipated Primary Completion Date :

Jan 29, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimatoprost SR - Dose A Study Eye: Participants will receive 1 - 3 Cycles of Bimatoprost SR administrations of Dose A Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.	Drug: Bimatoprost (SR) Study Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR.
Experimental: Bimatoprost SR - Dose B Study Eye: Participants received 1-3 Cycles of Bimatoprost SR administrations of Dose B Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.	Drug: Bimatoprost (SR) Study Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR.

Arm

Intervention/Treatment

Experimental: Bimatoprost SR - Dose A

Study Eye: Participants will receive 1 - 3 Cycles of Bimatoprost SR administrations of Dose A Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.

Drug: Bimatoprost (SR)

Study Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR.

Experimental: Bimatoprost SR - Dose B

Study Eye: Participants received 1-3 Cycles of Bimatoprost SR administrations of Dose B Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.

Drug: Bimatoprost (SR)

Study Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR.

Outcome Measures

Primary Outcome Measures

Retreatment or rescue administered for IOP [Up to 48 months]
Treatment modality determined by investigator.
Number of patients experiencing a treatment emergent adverse event [Baseline up to 48 months]
The number of patients who experienced one or more TEAE during the 48 month treatment period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of either Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.

Exclusion Criteria:

Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study.
Previous administration with Bimatoprost SR in the study eye.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Walman Eye Center /ID# 235240	Sun City	Arizona	United States	85351
2	Atlantis Eye Care /ID# 235530	Huntington Beach	California	United States	92647
3	Lakeside Vision Center /ID# 234970	Irvine	California	United States	92604
4	Global Research Foundation /ID# 237350	Los Angeles	California	United States	90041-1718
5	The Eye Research Foundation /ID# 234521	Newport Beach	California	United States	92663-3637
6	Byers Eye Institute Stanford /ID# 235544	Palo Alto	California	United States	94303
7	Foothill Eye Institute /ID# 235640	Pasadena	California	United States	91107
8	Connecticut Eye Consultants P.C. /ID# 234981	Danbury	Connecticut	United States	06810
9	Specialty Retina Center /ID# 236045	Coral Springs	Florida	United States	33067
10	Segal Drug Trials, Inc /ID# 235784	Delray Beach	Florida	United States	33484
11	International Research Center /ID# 238050	Tampa	Florida	United States	33603
12	Thomas Eye Group PC /ID# 235737	Sandy Springs	Georgia	United States	30328
13	Indiana University - Glick Eye Institute /ID# 235886	Indianapolis	Indiana	United States	46202
14	Midwest Eye Institute /ID# 237876	Indianapolis	Indiana	United States	46290
15	Tulane University /ID# 237632	New Orleans	Louisiana	United States	70112-2699
16	Ophthalmic Consultants of Boston /ID# 236534	Boston	Massachusetts	United States	02129
17	Clinical Eye Research of Boston LLC /ID# 234966	Winchester	Massachusetts	United States	01890
18	University of Michigan, Kellogg Eye Center /ID# 236496	Ann Arbor	Michigan	United States	48105
19	Fraser Eye Center /ID# 235790	Fraser	Michigan	United States	48026
20	Silverstein Eye Centers /ID# 237881	Kansas City	Missouri	United States	64034
21	Moyes Eye Center PC /ID# 234989	Kansas City	Missouri	United States	64154
22	Alterman Modi & Wolter /ID# 235248	Poughkeepsie	New York	United States	12603-2455
23	The Ohio State University /ID# 236790	Columbus	Ohio	United States	43210-1257
24	AMA Eyes Research Institute /ID# 235542	Marysville	Ohio	United States	43040
25	Dean McGee Eye Institute /ID# 236823	Oklahoma City	Oklahoma	United States	73104
26	Oklahoma Eye Surgeons /ID# 235849	Oklahoma City	Oklahoma	United States	73112
27	Drs Fine Hoffman & Sims LLC /ID# 235918	Eugene	Oregon	United States	97401
28	Ophthalmic Partners, PC /ID# 235741	Bala-Cynwyd	Pennsylvania	United States	19004
29	Scott and Christie and Associates /ID# 234593	Cranberry Township	Pennsylvania	United States	16066
30	Black Hills Regional Eye Institute /ID# 235075	Rapid City	South Dakota	United States	57701
31	Vance Thompson Vision /ID# 235072	Sioux Falls	South Dakota	United States	57108
32	Eye Specialty Group /ID# 235721	Memphis	Tennessee	United States	38120
33	Vanderbilt University Medical Center /ID# 237177	Nashville	Tennessee	United States	37232-0011
34	Advancing Vision Research /ID# 236681	Smyrna	Tennessee	United States	37167
35	ATX Clinical Trials Inc. dba Keystone Research /ID# 235868	Austin	Texas	United States	78731
36	Medical Center Ophthalmology Associates - Keystone Research /ID# 235787	San Antonio	Texas	United States	78240
37	Southern Utah Medical Research /ID# 235602	Saint George	Utah	United States	84790
38	Piedmont Eye Center /ID# 234534	Lynchburg	Virginia	United States	24502
39	Consultorio Oftalmologico Dr. Fabian Lerner /ID# 235855	Caba	Buenos Aires	Argentina	1122
40	Hospital Universitario Austral /ID# 237727	Pilar	Buenos Aires	Argentina	1629
41	Oftalmología Global /ID# 239187	Rosario	Santa Fe	Argentina	2000
42	Hospital Italiano /ID# 235851	Buenos Aires		Argentina	1181
43	Centro Privado de Ojos /ID# 241283	Ciudad Autonoma Buenos Aires		Argentina	1033
44	Centro oftalmologico Dr Charles /ID# 235881	Ciudad de Buenos Aires		Argentina	1116
45	Oftar Mendoza /ID# 240535	Mendoza		Argentina	1019
46	Eye Surgery Associates /ID# 235873	East Melbourne	Victoria	Australia	3002
47	Multiprofile Hospital for Active Treatment "Lozenetz" /ID# 244053	Sofiya	Sofia	Bulgaria	1407
48	Medical Center Oxycom Burgas /ID# 235580	Burgas		Bulgaria	8008
49	UMHAT Sveti Georgi /ID# 237027	Plovdiv		Bulgaria	4002
50	MHAT Hadzhi Dimitar /ID# 238248	Sliven		Bulgaria	8800
51	Medical Center - Smolyan OOD /ID# 242361	Smolyan		Bulgaria	4700
52	MHAT Dr. Bratan Shukerov /ID# 235498	Smolyan		Bulgaria	4700
53	Medical center for eye healt Focus Ltd /ID# 235575	Sofia		Bulgaria	1303
54	Pentagram Eye Hospital /Id# 235813	Sofia		Bulgaria	1309
55	Specialized Hospital for Active Treatment in Ocular Diseases "Zrenie" /ID# 235500	Sofia		Bulgaria	1408
56	Diagnostic consultative center Aleksandrovska /ID# 238105	Sofia		Bulgaria	1431
57	St. Sofia Hospital /ID# 235525	Sofia		Bulgaria	1618
58	Medical Center -Verea /ID# 235494	Stara Zagora		Bulgaria	6000
59	Medical center Orfey /ID# 237344	Stara Zagora		Bulgaria	6000
60	MHAT Trakia /ID# 238137	Stara Zagora		Bulgaria	6004
61	Specialized Ophthalmological Hospital for Active Treatment - Varna /ID# 235962	Varna		Bulgaria	9002
62	Ocni klinika Pardubice /ID# 235944	Pardubice		Czechia	530 02
63	Fakultni nemocnice Kralovske Vinohrady /ID# 234323	Praha		Czechia	100 34
64	Vseobecna fakultni nemocnice v Praze /ID# 234422	Praha		Czechia	128 08
65	Rigshospitalet Glostrup /ID# 235743	Glostrup	Hovedstaden	Denmark	2600
66	Universitatsklinikum Freiburg /ID# 238048	Freiburg im Breisgau	Baden-Wuerttemberg	Germany	79106
67	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 237069	Kiel	Schleswig-Holstein	Germany	24105
68	Klinikum Dresden Friedrichstadt /ID# 235308	Dresden		Germany	01067
69	Universitaetsmedizin Goettingen /ID# 237377	Goettingen		Germany	37075
70	Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 237247	Hamburg		Germany	20246
71	Asklepios Kinik Nord - Heidberg Augenklinik /ID# 235955	Hamburg		Germany	22417
72	St. Franziskus-Hospital /ID# 237714	Muenster		Germany	48145
73	Dietrich-Bonhoeffer-Klinikum /ID# 235262	Neubrandenburg		Germany	17036
74	Universitaetsmedizin Rostock /ID# 237263	Rostock		Germany	18057
75	Augenzentrum Dr Hamacher /ID# 235537	Starnberg		Germany	82319
76	Bugat Pal Korhaz /ID# 238144	Gyöngyös	Heves	Hungary	3200
77	Markusovszky Egyetemi Oktatokorhaz /ID# 237383	Szombathely	Vas	Hungary	9700
78	Budapest Retina Intezet /ID# 235950	Budapest		Hungary	1133
79	Jahn Ferenc Del-pesti Korhaz es Rendelointezet /ID# 237111	Budapest		Hungary	1204
80	Royal Victoria Eye and Ear Hospital /ID# 235546	Dublin		Ireland	2
81	Institute of Eye Surgery /ID# 235547	Waterford		Ireland	X91 DH9W
82	University of Catanzaro /ID# 238066	Catanzaro	Calabria	Italy	88100
83	Eye Clinic University of Catania /ID# 235573	Catania		Italy	95123
84	Ospedale Ss. Annunziata /ID# 236587	Chieti		Italy	66100
85	Fondazione IRCCS Policlinico /ID# 236909	Pavia		Italy	27100
86	University of Perugia /ID# 235811	Perugia		Italy	06156
87	Fondazione Bietti - Ospedale Britannico /ID# 235495	Rome		Italy	00184
88	Ospedale Fiorini di Terracina /ID# 237451	Terracina		Italy	04019
89	Southern Eye Specialists /ID# 236080	Christchurch	Canterbury	New Zealand	8013
90	Capital Eye Specialists /ID# 236112	Wellington		New Zealand	6011
91	Wojskowy Instytut Medyczny /ID# 237031	Warsaw	Mazowieckie	Poland	04-349
92	Optinum Profesorskie Centrum Okulistyki /ID# 237076	Gdansk	Pomorskie	Poland	80-809
93	Gabinet Okulistyczny Edward Wylegala /ID# 235946	Katowice		Poland	40-594
94	Medical Center Julianow /ID# 235961	Lodz		Poland	91-485
95	Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 235928	Olsztyn		Poland	10-424
96	S. Fyodorov Eye Microsurgery Federal State Institution /ID# 235984	Novosibirsk		Russian Federation	630071
97	Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236042	Omsk		Russian Federation	644024
98	Pretoria Eye Institute - Private Practice /ID# 235658	Pretoria	Gauteng	South Africa	0083
99	Somerset Eye Specialist Medical & Surgical Centre /ID# 235540	Somerset West	Western Cape	South Africa	7130
100	Norrlands University hospital /ID# 237553	Umea	Vasterbottens Lan	Sweden	581 85
101	The Princess Alexandra NHS Trust /ID# 234433	Harlow	Essex	United Kingdom	CM20 1QX
102	Oxford University Hospitals NHS Foundation Trust /ID# 237282	Oxford	Oxfordshire	United Kingdom	OX3 9DU
103	Epsom /ID# 235931	Epsom	Surrey	United Kingdom	KT18 7EG
104	Birmingham & Midland Eye Center /ID# 235067	Birmingham		United Kingdom	B18 7QH
105	Cambridge University Hospitals NHS Foundation Trust /ID# 238255	Cambridge		United Kingdom	CB2 0QQ
106	Mid Essex Hospitals NHS Trust /ID# 237776	Chelmsford		United Kingdom	CM1 7ET
107	East Suffolk and North Essex NHS Foundation Trust /ID# 234657	Colchester		United Kingdom	CO4 5JL
108	Mid-Cheshire Hospitals NHS Trust /ID# 235418	Crewe		United Kingdom	CW1 4QJ
109	Liverpool University Hospitals NHS Foundation Trust /ID# 237095	Liverpool		United Kingdom	L7 8XP
110	Liverpool University Hospitals NHS Foundation Trust /ID# 237321	Liverpool		United Kingdom	L7 8XP
111	Central Middlesex Hospital /ID# 236216	London		United Kingdom	NW10 7NS
112	King's College Hospital NHS Foundation Trust /ID# 237275	London		United Kingdom	SE5 9RS
113	York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 237683	York		United Kingdom	YO31 8HE