Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol
Completed · Phase 4
Conditions studied: Glaucoma
In brief
The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.
Key facts
- Study ID
- NCT01336569
- Run by
- Alcon Research
- People needed
- 50
- Starts
- 2011-02-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2013-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;
- Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);
- On a stable medication regimen for IOP reduction one week prior to the screening visit;
- Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;
- Sign informed consent;
- Other protocol-defined inclusion criteria may apply.
You may not qualify if…
- Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;
- Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;
- Infection in either eye;
- Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;
- Risk for visual field or visual acuity worsening, in the opinion of the investigator;
- Women of childbearing potential;
- Pregnant or lactating women;
- Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.
- Participation in another clinical study within 30 days before the screening visit;
- Other protocol-defined exclusion criteria may apply.
Where it is running
- Contact Alcon Call Center for Trial Locations — Fort Worth, Texas, United States
Full record on ClinicalTrials.gov
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