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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); Carteolol long-acting 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 carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from baseline in intraocular pressure at 8 weeks.re

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

Page last updated: August 23, 2015

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