Phase 4
Completed N=125
24-hr Intraocular Pressure Control With SIMBRINZA ®
Source: ClinicalTrials.gov NCT02770248 ↗Enrolled (actual)
125
Serious AEs
1.6%
Results posted
Jan 2018
Primary outcomePrimary: Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4 — -3.09; -0.60 mmHg
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4 |
-3.09; -0.60 | — |
| SECONDARY Least Squares Mean Change From Baseline in Daytime IOP at Week 4 |
-3.93; -0.51 | — |
| SECONDARY Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4 |
-1.88; -0.73 | — |
| SECONDARY Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 |
-3.28; -0.49; -5.05; -0.61; -4.03; -0.27 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of either open-angle glaucoma or ocular hypertension;
- Able to attend all study related visits and be housed overnight at clinical site for the study assessments;
- Willing and able to sign an informed consent form;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;
- Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;
- Ocular surgeries or procedures excluded by the protocol;
- Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
- Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;
- Other protocol-specific exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02770248). 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.