DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Phase 3
Completed
- Conditions
- Open Angle Glaucoma or Ocular Hypertension
- Interventions
- Drug: DE-111 ophthalmic solution
- Registration Number
- NCT01343082
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- Brief Summary
Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
Inclusion Criteria
- Diagnosed with open angle glaucoma or ocular hypertension
- Provided signed, written informed consent
- 20 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 DE-111 ophthalmic solution DE-111 ophthalmic solution
- Primary Outcome Measures
Name Time Method Change From Baseline in IOP (Intraocular Pressure) at End of Study Treatment period: Week 0 (Baseline) and Week 52 (End of Study)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Santen study sites
🇯🇵Osaka, Japan