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

Glaucoma, Open-Angle Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243567
• Other study ID #: MAF-AGN-OPH-GLA-010
• Secondary ID: 2009-012799-28
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2010
• Est. completion date: February 14, 2012

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: February 14, 2012
• Est. primary completion date: February 14, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Portugal,  Spain, 

References & Publications (1)

Gutierrez-Diaz E, Silva Cotta J, Muñoz-Negrete FJ, Gutierrez-Ortiz C, Morgan-Warren RJ, Maltman J. Bimatoprost/timolol fixed combination versus latanoprost in treatment-naïve glaucoma patients at high risk of progression: a pilot study. Clin Ophthalmol. 2014 Apr 10;8:725-32. doi: 10.2147/OPTH.S56735. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Average Intraocular Pressure (IOP)	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).	Baseline, Month 3
Secondary	Change From Baseline IOP	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).	Baseline, Month 3
Secondary	Percentage of Patients Reaching a Predefined Target Pressure Threshold	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.	Baseline, Month 3
Secondary	Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading	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.	Baseline, Month 3
Secondary	Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading	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.	Baseline, Month 3