Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
2 other identifiers
interventional
561
9 countries
9
Brief Summary
This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2010
Shorter than P25 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2010
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
March 12, 2013
CompletedMarch 29, 2013
March 1, 2013
1.3 years
August 4, 2010
February 7, 2013
March 22, 2013
Conditions
Outcome Measures
Primary Outcomes (4)
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Baseline, Week 12
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.
Week 2
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.
Week 6
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.
Week 12
Secondary Outcomes (2)
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
Baseline, Week 12
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
Baseline, Week 12
Study Arms (2)
bimatoprost/timolol formulation A
EXPERIMENTALOne drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
bimatoprost/timolol fixed combination ophthalmic solution
ACTIVE COMPARATOROne drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Interventions
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Eligibility Criteria
You may qualify if:
- Patient has ocular hypertension or glaucoma in both eyes
- Requires IOP-lowering therapy in each eye
You may not qualify if:
- Active or recurrent eye disease that would interfere with interpretation of study data in either eye
- History of any eye surgery or laser in either eye within 6 months
- Required chronic use of other eye medications during the study
- Anticipated wearing of contact lenses during the study.
- Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (9)
Unknown Facility
Artesia, California, United States
Unknown Facility
Sydney, New South Wales, Australia
Unknown Facility
Brno, Czechia
Unknown Facility
Leipzig, Germany
Unknown Facility
Budapest, Hungary
Unknown Facility
Tel Aviv, Israel
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Valencia, Spain
Unknown Facility
London, England, United Kingdom
Related Publications (1)
Goldberg I, Gil Pina R, Lanzagorta-Aresti A, Schiffman RM, Liu C, Bejanian M. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial. Br J Ophthalmol. 2014 Jul;98(7):926-31. doi: 10.1136/bjophthalmol-2013-304064. Epub 2014 Mar 25.
PMID: 24667994DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2010
First Posted
August 6, 2010
Study Start
October 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 29, 2013
Results First Posted
March 12, 2013
Record last verified: 2013-03