Ocular Hypertension, Open-angle Glaucoma
Conditions
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.
Interventions
DRUGDE-112
Topical ocular solution
DRUGDE-112 Vehicle Solution
Topical ocular solution
Topical ocular solution
Sponsors
Santen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure (IOP) | 29 days | Change from baseline in mean diurnal IOP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure (IOP) | 29 days | Percent change from baseline in mean diurnal IOP |
Countries
United States
Outcome results
None listed