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 |
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.
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.
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.
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2
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