Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue

Launched by ALCON RESEARCH · Sep 6, 2013

Keywords

ClinConnect Summary

This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

Gender

ALL

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.