Study of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension
This study has been completed.
Sponsor:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00372827
First Posted: September 7, 2006
Last Update Posted: November 21, 2016
Information provided by (Responsible Party):
Alcon Research
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Primary Open-angle Glaucoma Ocular Hypertension Pigment Dispersion Glaucoma | Drug: Brinzolamide 1% added to Travoprost 0.004% | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Mean diurnal intraocular pressure at month 3
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 245 |
| Study Start Date: | February 2004 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372827
Locations
| Germany | |
| Mainz Site | |
| Mainz, Germany, 55131 | |
Sponsors and Collaborators
Alcon Research
Investigators
| Study Director: | Anna Grau | Study Manager |
More Information
Publications:
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00372827 History of Changes |
| Other Study ID Numbers: |
CM-03-06 |
| First Submitted: | September 6, 2006 |
| First Posted: | September 7, 2006 |
| Last Update Posted: | November 21, 2016 |
| Last Verified: | May 2008 |
Additional relevant MeSH terms:
|
Hypertension Glaucoma Glaucoma, Open-Angle Ocular Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Timolol Travoprost Brinzolamide |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Carbonic Anhydrase Inhibitors Enzyme Inhibitors |