Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

NCT00652106 | Completed Phase 3

• 1 other identifier: 190342-019T
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP)

  Day 28

Study Arms (3)

1

EXPERIMENTAL

0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution

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

2

ACTIVE COMPARATOR

Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution

Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution

3

ACTIVE COMPARATOR

0.2% brimonidine ophthalmic solution

Drug: Brimonidine 0.2% ophthalmic solution

Interventions

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

0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)

Also known as: COMBIGAN®

1

Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution DRUG

Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)

2

Brimonidine 0.2% ophthalmic solution DRUG

Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)

Also known as: ALPHAGAN®

3

Eligibility Criteria

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

You may qualify if:

• Diagnosis of ocular hypertension or glaucoma
• Patient requires IOP-lowering therapy in both eyes

You may not qualify if:

• Uncontrolled medical conditions
• Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

El Paso, Texas, United States

Location

Related Links

• Link to Clinical Trial Results

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Brimonidine Tartrate, Timolol Maleate Drug Combination; Timolol; Ophthalmic Solutions; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 3, 2008
• Study Start: June 1, 2003
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: April 3, 2008

Record last verified: 2008-04

Locations

US (1)