Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Information source: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: OPC-1085EL ophthalmic solution (Drug); Latanoprost ophthalmic solution (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Otsuka Pharmaceutical Co., Ltd. Overall contact: Drug Information Center, Phone: +81-3-6361-7314
Summary
The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic
solution in comparison with latanoprost ophthalmic solution in subjects who are
insufficiently responsive to latanoprost ophthalmic solution.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Change from baseline in intraocular pressure at 8 weeks
Secondary outcome: Subject incidence and percentage, and event count of adverse events
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular
hypertension
Exclusion Criteria:
- Subjects with ocular conditions as defined by the protocol
Locations and Contacts
Drug Information Center, Phone: +81-3-6361-7314
Kansai Region, Japan; Recruiting
Additional Information
Starting date: April 2014
Last updated: July 3, 2014
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