Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®

This study is divided into 2 sequential phases for a total of 5 visits. Phase I of the study
is the open-labeled Screening/Eligibility Phase, which includes a Screening Visit followed by
2 Eligibility Visits. Phase II of the study is the randomized, double-masked Treatment Phase,
which includes 2 on-therapy visits: Visit 4 (at Week 2) and Visit 5 (Week 6, Exit Visit).
NOTE: This trial is being conducted in Europe, Latin America, and Asia. No US sites.

Inclusion Criteria:

- Diagnosis of open-angle glaucoma (including pseudoexfoliation or pigment dispersion
glaucoma) or ocular hypertension.

- Currently on treatment with Travoprost 0.004%/Timolol 0.5% prescribed as approved in
the country, on morning or evening dosing for at least 28 days prior to screening, and
in the opinion of the Investigator may benefit from further IOP lowering.

- Mean IOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least
1 eye (the same eye(s) ≥ 19 and ≤ 28 mmHg at 09:00 while on a Travoprost 0.004%/
Timolol 0.5% solution.

- Able to understand and sign an informed consent form that has been approved by an
Institutional Review Board/Ethics Committee.

- Willing and able to attend all study visits.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Women of childbearing potential: not postmenopausal for at least 1 year or less than 6
weeks since sterilization, currently pregnant; have a positive result on the urine
pregnancy test at Screening; intend to become pregnant during the study period;
breast-feeding; or not in agreement to use adequate birth control methods to prevent
pregnancy throughout the study.

- Mean IOP > 28 mmHg at any time point in either eye during the Screening/Eligibility
Phase.

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

- Severe central visual field loss in either eye.

- Chronic, recurrent or severe inflammatory eye disease in either eye.

- Ocular trauma in either eye within the past 6 months prior to the Screening visit.

- Ocular infection or ocular inflammation in either eye within the past 3 months prior
to the Screening visit.

- Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.

- Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to
approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye.

- Other ocular pathology (including severe dry eye) in either eye that may, in the
opinion of the Investigator, preclude the safe administration of any study medication.

- Intraocular surgery in either eye within the past 6 months prior to the Screening
visit.

- Ocular laser surgery in either eye within the past 3 months prior to the Screening
visit.

- Any other condition including severe illness which would make the subject, in the
opinion of the Investigator, unsuitable for the study.

- Asthma, history of asthma, or severe chronic obstructive pulmonary disease.

- Other protocol-defined exclusion criteria may apply.