Phase 4
Completed N=54
Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada
Source: ClinicalTrials.gov NCT01415401 ↗Enrolled (actual)
54
Serious AEs
1.8%
Results posted
Jul 2014
Primary outcomePrimary: Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline) — 22.24; -2.24 mmHg
Summary
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline) |
22.24; -2.24 | — |
| SECONDARY Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg) |
36.2 | — |
Eligibility Criteria
Inclusion Criteria
- Willing to sign an Informed Consent form.
- Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).
- Be on a stable IOP lowering regimen within 30 days of Screening Visit.
- IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1.
- IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
- Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye.
- Willing to follow instructions and able to attend required study visits.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Known history of hypersensitivity to any component of the preparations used in this study.
- Presence of primary or secondary glaucoma not listed in inclusion criterion #2.
- History of ocular herpes simplex.
- 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 3 months prior to the Screening Visit.
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- Progressive retinal or optic nerve disease from any cause.
- Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit.
- Pregnant or lactating.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01415401). 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.