A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00465803
First received: April 23, 2007
Last updated: May 22, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Open-angle Glaucoma Ocular Hypertension |
Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution Drug: Travoprost ophthalmic solution, 0.004% Drug: Timolol maleate ophthalmic solution, 0.5% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Compliance Study Comparing DuoTrav to TRAVATAN Plus Timolol Using the Dosing Aid |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Patient compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]Patient compliance will be measured with a dosing aid that records time and date of study drug administration
| Enrollment: | 81 |
| Study Start Date: | March 2007 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
DuoTrav
One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid
|
Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution
One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid
Other Name: DuoTrav
|
|
Travatan/Timolol
One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.
|
Drug: Travoprost ophthalmic solution, 0.004%
One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid
Other Name: TRAVATAN
Drug: Timolol maleate ophthalmic solution, 0.5%
One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients with open-angle glaucoma or ocular hypertension;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Visual acuity worse than 0.60;
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00465803 History of Changes |
| Other Study ID Numbers: | C-06-21 |
| Study First Received: | April 23, 2007 |
| Last Updated: | May 22, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
Open-angle glaucoma or ocular hypertension |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Timolol Travoprost Maleic acid Cloprostenol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Enzyme Inhibitors Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 19, 2013