Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension
Phase 3
Completed
- Conditions
- Open-angle GlaucomaOcular Hypertension
- Interventions
- Drug: Travoprost/Timolol Maleate Fixed Combination solution
- Registration Number
- NCT00928590
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
Inclusion Criteria
- Willing and able to sign an informed consent document.
- Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.
- Stable treatment of an IOP-lowering medication.
- Other protocol-defined inclusion criteria may apply.
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Exclusion Criteria
- Pregnant, breastfeeding, or not using adequate birth control.
- Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.
- Other protocol-defined exclusion criteria may apply.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DuoTrav APS Travoprost/Timolol Maleate Fixed Combination solution Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months
- Primary Outcome Measures
Name Time Method Adverse Events (AEs) 12 months
- Secondary Outcome Measures
Name Time Method