Exploratory Study of OPC-12759 Ophthalmic Suspension

February 19, 2015 updated by: Otsuka Pharmaceutical Co., Ltd.

Exploratory Study of OPC-12759 Ophthalmic Suspension in Patients With Keratoconjunctiva Epithelial Disorder

The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.

Study Overview

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hachioji, Japan
        • Kanto region
      • Ibaraki, Japan
        • Kansai Region
      • Ikoma, Japan
        • Kansai Region
      • Kobe, Japan
        • Kansai Region
      • Kure, Japan
        • Chugoku region
      • Kyoto, Japan
        • Kansai Region
      • Nagoya, Japan
        • Tokai region
      • Osaka, Japan
        • Kansai Region
      • Osakasayama, Japan
        • Kansai Region
      • Tokyo, Japan
        • Kanto region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
  2. Fluorescein corneal staining score of 3 or higher

Exclusion Criteria:

  1. Active ocular infection
  2. Vernal keratoconjunctivitis
  3. Recurrent corneal erosion
  4. Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
  5. Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
  6. Anticipated use of contact lens during the study.
  7. Insertion of punctal plug or fall out of punctal plug within 3 months
  8. Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
  9. Receipt of any investigational product within 4 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OPC-12759 ophthalmic suspension
OPC-12759 ophthalmic suspension 2%
Active Comparator: Sodium hyaluronate ophthalmic solution
Sodium hyaluronate ophthalmic solution 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Keratoconjunctival Staining Score From Baseline
Time Frame: Basekine, 4 weeks

Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better.

The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test.

Basekine, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Eiji Murakami, Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 13, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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