Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Phase 4

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination; Drug: dorzolamide hcl 2%/ timolol maleate 0.5% fixed combination; Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy.; Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combinatin as adjunctive to current prostaglandin therapy.

• Registration Number: NCT00822081
• Lead Sponsor: Bp Consulting, Inc

Brief Summary

This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomization process, each subject is allocated to recieve either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjuctive to a prostoglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1, and Month 3 for ophthalmic evaluations.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2009-01
• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-13
• Last Update Submitted: 2009-01-13
• Study First Posted: 2009-01-14
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Male or female over 18 yrs.
• Female subjects of childbearing potential must have negative pregnancy test and provide contraception.
• Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes.
• Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate.
• Subjects able to complete questionnaires and provide informed consent.

Exclusion Criteria

• Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control.
• Subjects wherein the study drugs are containdicated.
• Subjects who have had introcular surgery with 6 months (3 months for laser).
• Subjects with known side effects/ allergy or sensitivity to any component of study treatments.
• Subjects with any uncontrolled systemic disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination	brimonidine/timolol. Fixed-combination monotherapy.
2	dorzolamide hcl 2%/ timolol maleate 0.5% fixed combination	dorzolamide/timolol. Fixed-combination monotherapy.
3	brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy.	prostaglandin analogue+ brimonidine/timolol fixed combination.
4	dorzolamide hcl 2%/timolol maleate 0.5% fixed combinatin as adjunctive to current prostaglandin therapy.	prostaglandin analogue+dorzolamide/timolol fixed combination.

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean IOP.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Patient tolerability/comfort measured by Likert scale.	Month 1