Phase 4
Completed N=189
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
Source: ClinicalTrials.gov NCT01937312 ↗Enrolled (actual)
189
Serious AEs
0.2%
Results posted
Jun 2015
Primary outcomePrimary: Mean Diurnal Intraocular Pressure (IOP) at Week 6 — 17.01; 20.37 mmHg
Summary
The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Diurnal Intraocular Pressure (IOP) at Week 6 |
17.01; 20.37 | — |
| SECONDARY Mean Diurnal IOP Change From Baseline to Week 6 |
-5.69; -1.99 | — |
| SECONDARY Mean Diurnal IOP Percentage Change From Baseline to Week 6 |
-24.88; -8.50 | — |
| SECONDARY Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM) |
19.4; 21.4; 15.8; 20.2; 17.2; 19.9 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
- Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);
- Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;
- Able to understand and sign Informed Consent Document;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
- Any form of glaucoma other than open angle glaucoma or ocular hypertension;
- Severe central visual field loss;
- Chronic, recurrent, or severe inflammatory eye disease;
- Ocular trauma within the past 6 months;
- Ocular infection or ocular inflammation within the past 3 months;
- Best-corrected visual acuity score worse than approximately 20/80 Snellen;
- Eye surgery within the past 6 months;
- Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
- Use of any additional topical or systemic ocular hypertensive medication during the study;
- Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01937312). 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.