Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

A Randomized, Double-masked, Placebo- and Active-controlled, Multi-Center, Dose Escalation Trial of DE-104 Ophthalmic Solution in Japanese and Non-Japanese Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.

Inclusion Criteria:

• Provided signed, written informed consent.
• 18 years of age and older.
• Diagnosed with primary open-angle glaucoma or ocular hypertension.
• If a subject is a female of childbearing potential she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

• Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
• Presence of any abnormality or significant illness that could be expected to interfere with the study.