A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT

This is a two stage study.

Stage One will explore the dose response of three concentrations of DE-117 as monotherapy
compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as
adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo
will also be evaluated. In addition, the additive effect of adjunctive therapy of each
concentration will be compared with the corresponding monotherapy concentration.

Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as
monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117
concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117
monotherapy and 0.0015% tafluprost will also be evaluated.

Inclusion Criteria:

1. Male or Female, 18 years of age or older

2. Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes

3. Qualifying intraocular pressure (IOP) in at least one eye at Baseline

Exclusion Criteria:

1. Closed/barely open anterior chamber angle or a history of acute angle closure in
either eye

2. Anticipate the need to initiate or modify medication (systemic or topical) that is
known to affect intraocular pressure (IOP) during the study period

3. Females who are pregnant, nursing or planning a pregnancy

4. Presence of any abnormality or significant illness that could be expected to
interfere with the study.