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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01177098




Registration number
NCT01177098
Ethics application status
Date submitted
4/08/2010
Date registered
6/08/2010
Date last updated
29/03/2013

Titles & IDs
Public title
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
Scientific title
Secondary ID [1] 0 0
2010-021507-24
Secondary ID [2] 0 0
192024-050
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 0 0
Ocular Hypertension 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bimatoprost /timolol formulation A fixed combination ophthalmic solution
Treatment: Drugs - bimatoprost/timolol fixed combination ophthalmic solution

Experimental: bimatoprost/timolol formulation A - One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.

Active comparator: bimatoprost/timolol fixed combination ophthalmic solution - One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.


Treatment: Drugs: bimatoprost /timolol formulation A fixed combination ophthalmic solution
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.

Treatment: Drugs: bimatoprost/timolol fixed combination ophthalmic solution
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
Timepoint [2] 0 0
Week 2
Primary outcome [3] 0 0
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
Timepoint [3] 0 0
Week 6
Primary outcome [4] 0 0
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [1] 0 0
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
Timepoint [2] 0 0
Baseline, Week 12

Eligibility
Key inclusion criteria
* Patient has ocular hypertension or glaucoma in both eyes
* Requires IOP-lowering therapy in each eye
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
561
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Brno
Country [3] 0 0
Germany
State/province [3] 0 0
Leipzig
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
Israel
State/province [5] 0 0
Tel Aviv
Country [6] 0 0
Russian Federation
State/province [6] 0 0
Saint-Petersburg
Country [7] 0 0
Spain
State/province [7] 0 0
Valencia
Country [8] 0 0
United Kingdom
State/province [8] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01177098
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01177098