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

NCT01243567 | Completed Phase 4 Results

• 2 other identifiers: MAF-AGN-OPH-GLA-0102009-012799-28
• Study Type: interventional
• Target: 81
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change From Baseline IOP

  Baseline, Month 3

• Percentage of Patients Reaching a Predefined Target Pressure Threshold

  Baseline, Month 3

• Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading

  Baseline, Month 3

• Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading

  Baseline, Month 3

Study Arms (2)

bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution

ACTIVE COMPARATOR

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

latanoprost 0.005% ophthalmic solution

ACTIVE COMPARATOR

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

Interventions

bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution DRUG

Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.

Also known as: GANFort®

bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution

latanoprost 0.005% ophthalmic solution DRUG

Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.

Also known as: Xalatan®

latanoprost 0.005% ophthalmic solution

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Coimbra, Portugal

Location

Unknown Facility

Madrid, Spain

Location

Related Publications (1)

• Gutierrez-Diaz E, Silva Cotta J, Munoz-Negrete FJ, Gutierrez-Ortiz C, Morgan-Warren RJ, Maltman J. Bimatoprost/timolol fixed combination versus latanoprost in treatment-naive 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.

  PMID: 24748767 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Bimatoprost; Timolol; Ganfort; Latanoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Study Start: June 1, 2010
• Primary Completion: February 14, 2012
• Study Completion: February 14, 2012
• Last Updated: April 18, 2019
• Results First Posted: February 26, 2013

Record last verified: 2019-04

Locations

PT (1); ES (1)