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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Santen Inc.
- Enrollment
- 147
- Primary Endpoint
- Intraocular pressure (IOP)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
Concentration 4
Intervention: DE-112 (Drug)
Concentration 1
Intervention: DE-112 (Drug)
Concentration 2
Intervention: DE-112 (Drug)
Concentration 3
Intervention: DE-112 (Drug)
Timolol Maleate Ophthalmic Solution
Intervention: Timolol Maleate Solution (Drug)
Outcomes
Primary Outcomes
Intraocular pressure (IOP)
Time Frame: 29 days
Change from baseline in mean diurnal IOP
Secondary Outcomes
- Intraocular pressure (IOP)(29 days)