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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822081
• Other study ID #: COM0501
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2009
• Last updated: January 13, 2009
• Start date: January 2005
• Est. completion date: April 2006

Study information

• Verified date: January 2009
• Source: Bp Consulting, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
1 drop BID in each eye
• dorzolamide hcl 2%/ timolol maleate 0.5% fixed combination
1 drop BID in each eye
• brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy.
1 drop BID in each eye
• dorzolamide hcl 2%/timolol maleate 0.5% fixed combinatin as adjunctive to current prostaglandin therapy.
1 drop BID in each eye

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bp Consulting, Inc	Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean IOP.		12 weeks	No
Secondary	Patient tolerability/comfort measured by Likert scale.		Month 1	No