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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01177098
First received: August 4, 2010
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
 Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution
Drug: bimatoprost/timolol fixed combination ophthalmic solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).

  • Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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.

  • Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.

  • Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).


Enrollment: 561
Study Start Date: October 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: 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.
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.
 Drug: 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.
Other Name: GANFORT®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has ocular hypertension or glaucoma in both eyes
  • Requires IOP-lowering therapy in each eye

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177098

Locations
United States, California
Artesia, California, United States
Australia, New South Wales
Sydney, New South Wales, Australia
Czech Republic
Brno, Czech Republic
Germany
Leipzig, Germany
Hungary
Budapest, Hungary
Israel
Tel Aviv, Israel
Russian Federation
Saint-Petersburg, Russian Federation
Spain
Valencia, Spain
United Kingdom
London, England, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01177098     History of Changes
Other Study ID Numbers: 192024-050, 2010-021507-24
Study First Received: August 4, 2010
Results First Received: February 7, 2013
Last Updated: March 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Bimatoprost
Cloprostenol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 19, 2013