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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00372827
Enrollment
245
Registered
2006-09-07
Start date
2004-02-29
Completion date
2006-01-31
Last updated
2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DRUGBrinzolamide 1% added to Travoprost 0.004%

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean diurnal intraocular pressure at month 3

Secondary

MeasureTime frame
Individual intraocular pressures measured at 08:00, 12:00 and 16:00 at month 3.
Reduction from baseline in mean diurnal intraocular pressure and individual timepoints.
Visual acuity, Slit lamp biomicroscopy and adverse events during 3 months.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026