Study of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Official title:

Efficacy and Safety of Timolol Maleate 0.5% Compared to Brinzolamide 1% When Added to Travoprost 0.004% in Primary Open-angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372827
• Other study ID #: CM-03-06
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2006
• Last updated: November 18, 2016
• Start date: February 2004
• Est. completion date: January 2006

Study information

• Verified date: May 2008
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the efficacy and safety of Timolol 0.5% solution to Brinzolamide 1% each given twice daily when added to Travoprost 0.004% given each evening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are treated with any prostaglandin analogue monotherapy (excluding unoprostone) and who have an intraocular pressure between 19 and 32 mmHg at 08:00 hours.

Exclusion Criteria:

• Under 18 years

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Pigment Dispersion Glaucoma
• Primary Open-angle Glaucoma

Intervention

Drug:
• Brinzolamide 1% added to Travoprost 0.004%

Locations

Country	Name	City	State
Germany	Mainz Site	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Holló G, Chiselita D, Petkova N, Cvenkel B, Liehneova I, Izgi B, Berta A, Szaflik J, Turacli E, Stewart WC. The efficacy and safety of timolol maleate versus brinzolamide each given twice daily added to travoprost in patients with ocular hypertension or p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean diurnal intraocular pressure at month 3
Secondary	Individual intraocular pressures measured at 08:00, 12:00 and 16:00 at month 3.
Secondary	Reduction from baseline in mean diurnal intraocular pressure and individual timepoints.
Secondary	Visual acuity, Slit lamp biomicroscopy and adverse events during 3 months.