SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

• Status: Completed
• Trial end date: 2018-02-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Bimatoprost; Brimonidine Tartrate; Brinzolamide; Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost

Criteria

Inclusion Criteria:

• Diagnosis of either open-angle glaucoma or ocular hypertension;

• Must sign an informed consent form;

• Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00.

• Willing and able to attend all study visits;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;

• Any form of glaucoma other than open-angle glaucoma or ocular hypertension;

• Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;

• Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;

• Other protocol-specified exclusion criteria may apply.