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

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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Timolol maleate Latanoprost Bimatoprost

U.S. FDA Resources

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

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
Ocular Hypertension
Eye Diseases
Timolol
Latanoprost
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 23, 2013