Safety and Efficacy of Changing to Duo-Travatan in Patients Uncontrolled on Timolol
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01336569
First received: April 14, 2011
Last updated: June 7, 2012
Last verified: June 2012
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Purpose
The purpose of this study to assess the safety and IOP-lowering efficacy of changing to Duo-Travatan from prior Timolol 0.5% monotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Drug: Travoprost/Timolol Maleate Fixed Combination |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Mean IOP Change at the final visit from baseline from prior beta-blocker monotherapy. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | April 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
DuoTrav
Single arm study. Transition to Duo-Travatan from prior therapy (historical control)
|
Drug: Travoprost/Timolol Maleate Fixed Combination
Patients switch from prior therapy to Travoprost/Timolol administered once daily for up to 6 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of ocular hypertension
- Primary open-angle or pigment dispersion glaucoma in both eyes
- IOP of between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye)
- Wiliness to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study
Exclusion Criteria:
- Known medical history of allergy, hypersensitivity or poor tolerance to any component of Duo-Travatan® that is deemed clinically significant in the opinion of the Principal Investigator
- Corneal dystrophies in either eye
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment
- Bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker
- History of severe allergic rhinitis
- A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject
- Participation in any other investigational study within 30 days prior to the Screening Visit
Contacts and Locations More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01336569 History of Changes |
| Other Study ID Numbers: | SMA-09-26 |
| Study First Received: | April 14, 2011 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Brazil: National Health Surveillance Agency Brazil: Ethics Committee United States: Food and Drug Administration |
Keywords provided by Alcon Research:
|
Primary open-angle glaucoma Ocular hypertension Pigment dispersion glaucoma |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Timolol Travoprost Maleic acid 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 |
ClinicalTrials.gov processed this record on May 19, 2013