Overview

Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
Summary
To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Santen Inc.
Treatments:
Maleic acid
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
Criteria
Inclusion Criteria:

- Provide signed, written informed consent

- 18 yeas of age and older

- Diagnosed with primary open-angle glaucoma or ocular hypertension

- Female subject of childbearing potential must utilize reliable contraceptive
throughout the study and have a negative urine pregnancy test prior to enrollment into
this study

- Meet specific Visit 2, Day 0 (Baseline)criteria at baseline

Exclusion Criteria:

- Females who are pregnant, nursing or planning a pregnancy

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