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
Overview
- Phase
- Phase 1
- Intervention
- DE-112 Vehicle Solution
- Conditions
- Open-angle Glaucoma
- Sponsor
- Santen Inc.
- Enrollment
- 147
- Primary Endpoint
- Intraocular pressure (IOP)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.
Detailed Description
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.
Investigators
Eligibility 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.
Arms & Interventions
Vehicle Solution
Intervention: DE-112 Vehicle Solution
Concentration 4
Intervention: DE-112
Concentration 1
Intervention: DE-112
Concentration 2
Intervention: DE-112
Concentration 3
Intervention: DE-112
Timolol Maleate Ophthalmic Solution
Intervention: Timolol Maleate Solution
Outcomes
Primary Outcomes
Intraocular pressure (IOP)
Time Frame: 29 days
Change from baseline in mean diurnal IOP
Secondary Outcomes
- Intraocular pressure (IOP)(29 days)