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

Ocular Hypertension Clinical Trial

Official title:

An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157364
• Other study ID #: 192024-041D
• Secondary ID: 2011-005091-42
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 23, 2010
• Est. completion date: August 9, 2016

Study information

• Verified date: March 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 9, 2016
• Est. primary completion date: July 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of open angle glaucoma or ocular hypertension

Exclusion Criteria:

• Uncontrolled medical conditions

• Anticipated wearing of contact lenses during the study

Related Conditions & MeSH terms

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

Intervention

Drug:
• bimatoprost 20 µg generation 2
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
• 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).
• 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).
• 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).
• bimatoprost 15 µg generation 1
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
• bimatoprost 10 µg generation 1
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
• 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.

Locations

Country	Name	City	State
Australia	Melbourne Eye Specialists	Fitzroy
Australia	Eye Associates	Sydney New South Wales
Belgium	UZ Leuven, Campus St. Rafael	Dienst Oogheelkunde
Brazil	Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia	Sao Paulo
Canada	Institut de l'œil des Laurentides	Boisbriand	Quebec
Canada	A.C. S. Crichton Prof. Corp	Calgary	Alberta
Canada	Anjema Eye Institute	Chatham	Ontario
Canada	Eye Care Center	Halifax	Nova Scotia
Canada	Galen Eye Centre	Kingston	Ontario
Canada	Ivey Eye Institute	London	Ontario
Canada	Clarity Eye Institute	Vaughan
Germany	Staedtisches Klinikum Department of Opthalmology	Karlsruhe
Israel	Kaplan Medical Center	Rohovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	The Sam Rothberg Glaucoma Center,	Tel-Hashomer
Philippines	Asian Eye Institute	Makati City
Philippines	Pacific Eye and Laser Institute (PELI)	Makati City
Philippines	St. Lukes Medical Center-Quezon City	Metro Manila
Singapore	Singapore National Eye Center	Singapore
Spain	Valles Oftalmologia Recerca, Hospital General de Catalunya,	Sant Cugat
Spain	Fundacion Oftalmologica Del Mediterraneo	Valencia
United States	Sall Research Medical Center	Artesia	California
United States	Emory University, The Emory Eye Center	Atlanta	Georgia
United States	Keystone Research LTD	Austin	Texas
United States	Glaucoma Consultants	Baltimore	Maryland
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Tufts Medical Center/New England Eye Center	Boston	Massachusetts
United States	The Eye Associates of Manatee	Bradenton	Florida
United States	Charlotte Eye Ear Nose & Throat Associates, PA	Charlotte	North Carolina
United States	Scott & Christie and Associates	Cranberry Township	Pennsylvania
United States	Glaucoma Associates of TX	Dallas	Texas
United States	Cornerstone Eye Care	High Point	North Carolina
United States	Moyes Eye Center	Kansas City	Missouri
United States	Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego	La Jolla	California
United States	Doheny Eye Institute	Los Angeles	California
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	ActivMed Practices & Research	Methuen	Massachusetts
United States	Glaucoma Associates of NY	New York	New York
United States	Specialty Eye Care	Parker	Colorado
United States	Philadelphia Eye Associates	Philadelphia	Pennsylvania
United States	Legacy Good Samaritan - Devers Eye Institute	Portland	Oregon
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Shasta Eye Medical Group, Inc.	Redding	California
United States	Rochester Ophthalmological Group PC	Rochester	New York
United States	Coastal Research Associates	Roswell	Georgia
United States	Grutzmacher and Lewis, Inc.	Sacramento	California
United States	Focus Clinical Research	Salt Lake City	Utah
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	R and R Eye Research	San Antonio	Texas
United States	Pacific Eye Surgeons	San Luis Obispo	California
United States	Northern New Jersey Eye Institute PA	South Orange	New Jersey
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Springfield Clinic	Springfield	Illinois
United States	Wolstan & Goldberg Eye Associates	Torrance	California
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Clinical Eye Research of Boston/ Charles River Eye Associates	Winchester	Massachusetts
United States	James D. Branch, MD	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Germany,  Israel,  Philippines,  Singapore,  Spain, 

References & Publications (1)

Craven ER, Walters T, Christie WC, Day DG, Lewis RA, Goodkin ML, Chen M, Wangsadipura V, Robinson MR, Bejanian M; Bimatoprost SR Study Group. 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients. Drugs. 2020 Feb;80(2):167-179. doi: 10.1007/s40265-019-01248-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye	IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.	Baseline, Month 24
Secondary	Time-Matched Intraocular Pressure (IOP) in the Study Eye	IOP is a measurement of the fluid pressure inside the study eye.	Baseline to Month 6
Secondary	Mean Diurnal IOP in the Study Eye	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.	Baseline, Month 6
Secondary	Time to Rescue Treatment or Re-Treatment in the Study Eye	Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.	24 Months