Phase 4 Completed N=86 Randomized Single-blind Treatment

Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

Open-angle glaucoma · Hypertension

Source: ClinicalTrials.gov NCT01978600 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcomePrimary: Mean Nocturnal IOP at Week 4 — 24.2; 23.6; 18.6; 18.9 mmHg

Summary

The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.