Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

NCT01151904 | Terminated Phase 4 Results

• 1 other identifier: MA-COM004
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.

Conditions

Glaucoma, Angle-Closure

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Intraocular Pressure (IOP)

  IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.

  Baseline, Week 12

Secondary Outcomes (2)

• Change From Baseline in IOP

  Baseline, Week 2, Week 6

• Percentage of Responders With an IOP Reduction ≥20% From Baseline

  Baseline, Week 12

Study Arms (1)

COMBIGAN® with Latanoprost

EXPERIMENTAL

Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.

Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution; Drug: latanoprost

Interventions

brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution DRUG

COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.

Also known as: COMBIGAN®

COMBIGAN® with Latanoprost

latanoprost DRUG

Latanoprost administered in the affected eye(s) as prescribed by physician.

COMBIGAN® with Latanoprost

Eligibility Criteria

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

You may qualify if:

• Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
• Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
• Diagnosis of chronic angle-closure glaucoma
• Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.

You may not qualify if:

• Known allergy or hypersensitivity to COMBIGAN®
• Corneal abnormalities that would preclude accurate IOP readings
• Any other active ocular disease other than glaucoma or ocular hypertension
• Ocular surgery within the past 3 months.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Bangkok, Thailand

Location

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Brimonidine Tartrate; Timolol; Brimonidine Tartrate, Timolol Maleate Drug Combination; Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Morpholines; Oxazines; Drug Combinations; Pharmaceutical Preparations; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

Due to lack of enrollment, this study was discontinued early and the outcome measures were not analyzed.

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2010
• First Posted: June 29, 2010
• Study Start: November 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 6, 2013
• Results First Posted: February 6, 2013

Record last verified: 2013-01

Locations

TH (1)