Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

September 23, 2010

Primary Completion Date

July 27, 2016

Study Completion Date

August 9, 2016

Conditions
Open-Angle GlaucomaOcular Hypertension
Interventions
DRUG

bimatoprost 20 µg generation 2

Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.

DRUG

bimatoprost 15 µg generation 2

Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

DRUG

bimatoprost 10 µg generation 2

Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

DRUG

bimatoprost 6 µg generation 2

Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

DRUG

bimatoprost 15 µg generation 1

Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.

DRUG

bimatoprost 10 µg generation 1

Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.

DRUG

bimatoprost 0.03%

One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Trial Locations (57)

1200

Asian Eye Institute, Makati City

1209

Pacific Eye and Laser Institute (PELI), Makati City

2000

Eye Associates, Sydney New South Wales

3065

Melbourne Eye Specialists, Fitzroy

10003

Glaucoma Associates of NY, New York

11563

Ophthalmic Consultants of Long Island, Lynbrook

14618

Rochester Ophthalmological Group PC, Rochester

16066

Scott & Christie and Associates, Cranberry Township

19148

Philadelphia Eye Associates, Philadelphia

21204

Glaucoma Consultants, Baltimore

27101

James D. Branch, MD, Winston-Salem

27262

Cornerstone Eye Care, High Point

28210

Charlotte Eye Ear Nose & Throat Associates, PA, Charlotte

30076

Coastal Research Associates, Roswell

30322

Emory University, The Emory Eye Center, Atlanta

34209

The Eye Associates of Manatee, Bradenton

46015

Fundacion Oftalmologica Del Mediterraneo, Valencia

52621

The Sam Rothberg Glaucoma Center,, Tel Litwinsky

62703

Springfield Clinic, Springfield

64154

Moyes Eye Center, Kansas City

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

75231

Glaucoma Associates of TX, Dallas

76100

Kaplan Medical Center, Rohovot

76133

Staedtisches Klinikum Department of Opthalmology, Karlsruhe

78229

R and R Eye Research, San Antonio

78240

Medical Center Ophthalmology Associates, San Antonio

78731

Keystone Research LTD, Austin

80134

Specialty Eye Care, Parker

84107

Focus Clinical Research, Salt Lake City

90033

Doheny Eye Institute, Los Angeles

90505

Wolstan & Goldberg Eye Associates, Torrance

90701

Sall Research Medical Center, Artesia

92093

Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego, La Jolla

93401

Pacific Eye Surgeons, San Luis Obispo

95670

Martel Eye Medical Group, Rancho Cordova

95815

Grutzmacher and Lewis, Inc., Sacramento

96002

Shasta Eye Medical Group, Inc., Redding

97210

Legacy Good Samaritan - Devers Eye Institute, Portland

98801

Wenatchee Valley Medical Center, Wenatchee

99204

Spokane Eye Clinical Research, Spokane

168751

Singapore National Eye Center, Singapore

02111

Tufts Medical Center/New England Eye Center, Boston

02114

Ophthalmic Consultants of Boston, Boston

01844

ActivMed Practices & Research, Methuen

01890

Clinical Eye Research of Boston/ Charles River Eye Associates, Winchester

07079

Northern New Jersey Eye Institute PA, South Orange

Leuven 3000

UZ Leuven, Campus St. Rafael, Dienst Oogheelkunde

04023-062

Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia, São Paulo

T3E-7M8

A.C. S. Crichton Prof. Corp, Calgary

B3H 2Y9

Eye Care Center, Halifax

N7M 5J7

Anjema Eye Institute, Chatham

K7K 6Z6

Galen Eye Centre, Kingston

N6A 4V2

Ivey Eye Institute, London

J7H 1S6

Institut de l'œil des Laurentides, Boisbriand

L4K 0C5

Clarity Eye Institute, Vaughan

Quezon City 1112

St. Lukes Medical Center-Quezon City, Metro Manila

08195

Valles Oftalmologia Recerca, Hospital General de Catalunya,, Sant Cugat del Vallès

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY