Phase 4
Completed N=50
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America
Source: ClinicalTrials.gov NCT01518244 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8 — -3.60 milllimeters mercury (mmHg)
Summary
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8 |
-3.60 | — |
| SECONDARY Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8 |
55.3 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
- On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
- IOP considered safe in both eyes in order to assure clinical stability of vision and optic nerve throughout the study period.
- Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
- IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Presence of other primary or secondary glaucoma.
- History of ocular herpes simplex.
- Any abnormality preventing reliable applanation tonometry.
- Corneal dystrophies.
- Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
- Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Screening Visit.
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.
- Progressive retinal or optic nerve disease from any cause.
- Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
- Pregnant or lactating.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01518244). 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.