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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:January 2011
End Date:February 2012

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A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects
with primary open-angle glaucoma or ocular hypertension.

This study will be conducted in two stages. Stage One is an open-label, adaptive
dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic
solution enrolling a total of 24 subjects.

Stage Two of the study is a randomized, double-masked, placebo- and active-controlled,
parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of
DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.

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.
We found this trial at
2
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San Antonio, TX
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Austin, TX
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