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

This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a
Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups
for the duration of the study, based upon commercial availability.

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.