NCT00650338CompletedPhase 2
A Randomized, Double-masked, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Santen Inc.
- Enrollment
- 165
- Locations
- 14
- Primary Endpoint
- To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
Study Overview
Brief Summary
To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension
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
- •Provided signed, written informed consent.
- •Diagnosed with primary open-angle glaucoma or ocular hypertension.
- •18 years of age and older.
- •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.
Arms & Interventions
1
Experimental
<described in intervention>
Intervention: DE-104 ophthalmic solution, low concentration (Drug)
2
Experimental
<described in intervention>
Intervention: DE-104 ophthalmic solution, medium concentration (Drug)
3
Experimental
<described in intervention>
Intervention: DE-104 ophthalmic solution, high concentration (Drug)
4
Placebo Comparator
<described in intervention>
Intervention: Placebo (Drug)
5
Active Comparator
<described intervention>
Intervention: 0.005% latanoprost (Drug)
Outcomes
Primary Outcomes
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
Time Frame: 28 days
Secondary Outcomes
- To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.(35 days)
Investigators
Study Sites (14)
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