An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects

NCT00811564 | Completed Phase 4 Results

• 1 other identifier: GMA-COM-08-008
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP) at Week 12

  Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.

  Week 12

Study Arms (2)

1

ACTIVE COMPARATOR

Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution

Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution

2

ACTIVE COMPARATOR

Latanoprost 0.005% ophthalmic solution

Drug: latanoprost 0.005%

Interventions

fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution DRUG

1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day

Also known as: Combigan™

1

latanoprost 0.005% DRUG

1 drop of study medication taken once daily

Also known as: Xalatan™

2

Eligibility Criteria

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

You may qualify if:

• Be at least 18 years of age;
• Give written informed consent;
• Be in good general health as determined by your doctor;
• Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
• If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
• Understand the study instructions, and be able to follow the study instructions; and
• Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

You may not qualify if:

• Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
• Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
• Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Slingerlands, New York, United States

Location

Related Publications (1)

• Katz LJ, Rauchman SH, Cottingham AJ Jr, Simmons ST, Williams JM, Schiffman RM, Hollander DA. Fixed-combination brimonidine-timolol versus latanoprost in glaucoma and ocular hypertension: a 12-week, randomized, comparison study. Curr Med Res Opin. 2012 May;28(5):781-8. doi: 10.1185/03007995.2012.681036. Epub 2012 Apr 25.

  PMID: 22458918 DERIVED

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

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

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; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Brimonidine Tartrate; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

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

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 19, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 21, 2011
• Results First Posted: September 21, 2011

Record last verified: 2011-08

Locations

US (1)