Phase 4
Completed N=188
SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)
Source: ClinicalTrials.gov NCT02419508 ↗Enrolled (actual)
188
Serious AEs
0.5%
Results posted
Nov 2018
Primary outcomePrimary: Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6 — -5.6; -2.1 mmHg — p=< 0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6 |
-5.6; -2.1 | < 0.001 sig |
| SECONDARY Mean Diurnal IOP at Week 6 |
17.2; 20.9 | <0.001 sig |
| SECONDARY Mean Percentage Change From Baseline in Diurnal IOP at Week 6 |
-24.7; -9.5 | <0.001 sig |
| SECONDARY Mean Change From Baseline in IOP at 11:00 at Week 6 |
22.4; 22.6; -7.0; -2.4 | <0.001 sig |
| SECONDARY Mean Percentage Change From Baseline in IOP at 11:00 at Week 6 |
-31.3; -10.8 | <0.001 sig |
| SECONDARY Mean Change From Baseline in IOP at 09:00 at Week 6 |
23.4; 23.4; -4.9; -2.5 | <0.001 sig |
| SECONDARY Mean Percentage Change From Baseline at 09:00 at Week 6 |
-21.0; -10.9 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of either open-angle glaucoma or ocular hypertension;
- Must sign an informed consent form;
- Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00.
- Willing and able to attend all study visits;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
- Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
- Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
- Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02419508). 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.