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NCT00471380 Clinical Trial

A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

Official title:
A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00471380
Other study ID # IT-04-04
Secondary ID EudraCT 20060036
Status Completed
Phase Phase 4
First received May 8, 2007
Last updated March 10, 2010
Start date March 2007

Study information
Verified date March 2010
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority Agenzua Italiana del Farmaco: Italy
Study type Interventional

Clinical Trial Summary

Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Written informed consent

- Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension

- Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM

- Stable visual field in last 6 months

- 6 weeks wash out from previous topical medications

Exclusion Criteria:

- Age

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• travoprost 0.004% and brinzolamide 1%
Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.)
• fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle
group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).

Locations
Country Name City State
Italy Catania Catania

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intra Ocular Pressure (IOP) Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points Baseline, end of each period (week 8, week 16, week 24) Yes
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