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Phase 4 Completed N=49 Treatment

Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

Source: ClinicalTrials.gov NCT01336569 ↗
Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Jul 2013
Primary outcomePrimary: Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy) — -5.0 millimeters mercury (mmHg)

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)
-5.0

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01336569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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