Phase 4
Completed N=74
AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure
Source: ClinicalTrials.gov NCT01484951 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) — 18.22; -3.56 millimeters mercury (mmHg)
Summary
The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) |
18.22; -3.56 | — |
| SECONDARY Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy |
54.3 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit.
- Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening.
- Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
- Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator.
- Any abnormality preventing reliable applanation tonometry in either eye.
- Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
- Pregnant or lactating.
- Participation in any other investigational study within 30 days of screening visit.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01484951). 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.