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Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01243567
First received: November 17, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.


Condition Intervention Phase
Glaucoma, Open-Angle
Drug: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
Drug: latanoprost 0.005% ophthalmic solution
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Average Intraocular Pressure (IOP) [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).


Secondary Outcome Measures:
  • Change From Baseline IOP [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).

  • Percentage of Patients Reaching a Predefined Target Pressure Threshold [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.

  • Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.

  • Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.


Enrollment: 81
Study Start Date: June 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Drug: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Other Name: GANFort®
Active Comparator: latanoprost 0.005% ophthalmic solution
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Drug: latanoprost 0.005% ophthalmic solution
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Other Name: Xalatan®

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma that has never been treated
  • Visual Acuity 20/60 or better in each eye

Exclusion Criteria:

  • Eye surgery within 3 months
  • Any refractive eye surgery
  • Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction [heart attack])
  • Eye inflammation or eye infection within 3 months
  • Eye trauma within 6 months
  • Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243567

Locations
Portugal
Coimbra, Portugal
Spain
Madrid, Spain
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01243567     History of Changes
Other Study ID Numbers: MAF-AGN-OPH-GLA-010, 2009-012799-28
Study First Received: November 17, 2010
Results First Received: January 22, 2013
Last Updated: January 22, 2013
Health Authority: Spain: Agency for Medicines and Medical Devices (AEMPS)
Portugal: National Authority for Medicines and Health Products (INFARMED)

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension
Bimatoprost
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014