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Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01068964
First received: February 12, 2010
Last updated: December 16, 2011
Last verified: December 2011
History of Changes
  Purpose

This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension


Condition Intervention
Open-angle Glaucoma
Ocular Hypertension
 Drug: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution
Drug: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.


Enrollment: 235
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.03% Bimatoprost/0.5% Timolol in Same Bottle
Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
 Drug: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution
One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
Other Name: Bottle 1: Ganfort®
Active Comparator: 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles
Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
 Drug: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution
One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
Other Names:
  • Bottle 1: Lumigan®
  • Bottle 2: Timoptol®

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes
  • Eye pressure lowering topical medications are not working
  • Visual acuity is at least 0.2 in each eye

Exclusion Criteria:

  • Uncontrolled systemic disease
  • Any other active eye disease other than glaucoma or ocular hypertension
  • Significant visual field loss or evidence of progressive visual field loss within the last year
  • Anticipated wearing of contact lenses during the study
  • Required chronic use of other ocular medications during the study
  • Eye surgery or laser treatment within 12 weeks prior to study enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068964

Locations
China
Beijing, China
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01068964     History of Changes
Other Study ID Numbers: 192024-052
Study First Received: February 12, 2010
Results First Received: December 16, 2011
Last Updated: December 16, 2011
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
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