Effect of SIMBRINZA™ As an Added Therapy to a Prostaglandin Analogue
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension), Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/3/2014 |
Start Date: | October 2013 |
End Date: | October 2014 |
Contact: | Alcon Call Center |
Email: | alcon.medinfo@alcon.com |
Phone: | 1-888-451-3937 |
Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue
The purpose of this study is to demonstrate the additive effect of brinzolamide
1%/brimonidine 0.2% (SIMBRINZA™) in subjects with either open angle glaucoma or ocular
hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.
1%/brimonidine 0.2% (SIMBRINZA™) in subjects with either open angle glaucoma or ocular
hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.
This study is divided into 2 sequential phases. The Screening/Eligibility phase includes one
screening visit and two eligibility visits, during which subjects will washout of all other
IOP-lowering medications and dose with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled
in each eye once daily for 28 days. Subjects who meet all inclusion/exclusion criteria will
be randomized at the second eligibility visit. The Treatment phase consists of two
on-therapy visits (Week 2 and Week 6).
screening visit and two eligibility visits, during which subjects will washout of all other
IOP-lowering medications and dose with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled
in each eye once daily for 28 days. Subjects who meet all inclusion/exclusion criteria will
be randomized at the second eligibility visit. The Treatment phase consists of two
on-therapy visits (Week 2 and Week 6).
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);
- 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.
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