NCT00657579
Completed
Phase 2
A Randomized, Double-Masked, Parallel-Group, Dose-Response Trial of DE-104 Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Overview
- Phase
- Phase 2
- Intervention
- DE-104 ophthalmic solution, low concentration
- Conditions
- Open-Angle Glaucoma
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Locations
- 1
- Status
- Completed
- Last Updated
- 17 years ago
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with primary open-angle glaucoma or ocular hypertension.
- •Provided signed, written informed consent.
- •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
Intervention: DE-104 ophthalmic solution, low concentration
2
Intervention: DE-104 ophthalmic solution, medium concentration
3
Intervention: DE-104 ophthalmic solution, high concentration
4
Intervention: DE-104 vehicle
Outcomes
Primary Outcomes
Not specified
Study Sites (1)
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