Ocular Hypertension, Open-Angle Glaucoma
Conditions
Brief summary
To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.
Interventions
DRUGDE-104 medium concentration
Topical ocular application
DRUGDE-104 high concentration
Topical ocular application
DRUGPlacebo
Topical ocular application
Topical ocular application
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
* Provided signed, written informed consent. * 18 years of age and older. * Diagnosed with primary open-angle glaucoma or ocular hypertension. * If a subject is a female of childbearing potential she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
Exclusion criteria
* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. * Presence of any abnormality or significant illness that could be expected to interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the safety and efficacy of two concentrations of DE-104 ophthalmic solution with placebo and 0.005% latanoprost in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension. | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension. | 15 days |
Countries
United States
Outcome results
None listed