Phase 4
N=86
Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension
Open-Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01978600 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Mean Nocturnal IOP at Week 4 — 24.2; 23.6; 18.6; 18.9 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension (Drug); Timolol Maleate 0.5% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Nocturnal IOP at Week 4 |
24.2; 23.6; 18.6; 18.9 | — |
| SECONDARY Mean Diurnal IOP at Week 4 |
23.2; 22.2; 17.3; 17.7 | — |
| SECONDARY Mean 24-hour IOP at Week 4 |
23.6; 22.8; 17.9; 18.2 | — |
Summary
The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
- Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
- Must sign an Informed Consent form.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
- Severe central visual field loss in either eye.
- Chronic, recurrent or severe inflammatory eye disease.
- Ocular trauma or ocular surgery within the past 6 months.
- Ocular infection or ocular inflammation within the past 3 months.
- Clinically significant or progressive retinal disease.
- Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
- Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
- Any medical condition that would preclude the safe administration of a topical beta-blocker.
- Cannot safely discontinue all glucocorticoids administered by any route.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01978600). 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.