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NCT00440141 Clinical Trial

Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00440141
Other study ID # MA-AP01
Secondary ID
Status Completed
Phase Phase 4
First received February 22, 2007
Last updated December 26, 2007
Start date July 2006
Est. completion date March 2007

Study information
Verified date December 2007
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Glaucoma or ocular hypertension in both eyes

- Currently being treated with latanoprost 0.005% QD

- IOP greater than or equal to 18mm Hg on latanoprost 0.005%

- Best-corrected VA of 20/200 or better in each eye

- Visual field within 6 months of study entry

Exclusion Criteria:

- Secondary glaucoma

- Active intraocular inflammation or macular edema

- Intraocular surgery or laser surgery within the past 3 months

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• latanoprost 0.005% eye drops and brimonidine 0.1% eye drops
latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months
• latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops
latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary IOP Month 3 No
Secondary Tolerability Month 3 No
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