Dose-response Study of OPC-12759 Ophthalmic Suspension

January 20, 2014 updated by: Otsuka Pharmaceutical Co., Ltd.
The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.

Study Overview

Study Type

Interventional

Enrollment (Actual)

290

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

      • Tokyo, Japan
        • Otsuka Pharmaceutical Co., Ltd.

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. Outpatient.
  2. Subjective complaint of dry eye that has been present for minimum 20 months.
  3. Primary ocular discomfort severity is moderate to severe.
  4. Corneal - conjunctival damage is moderate to severe.
  5. Unanesthetized Schirmer's test score of 7mm/5minutes or less.
  6. Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

  1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
  2. Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
  3. Anticipated use of contact lens during the study.
  4. Any history of ocular surgery within 12 months.
  5. Female patients who are pregnant, possibly pregnant or breast feeding;
  6. Known hypersensitivity to any component of the study drug or procedural medications.
  7. 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.5% OPC-12759
0.5% OPC-12759 (rebamipide) ophthalmic suspension
Experimental: 1% OPC-12759
1% OPC-12759 (rebamipide) ophthalmic suspension
Experimental: 2% OPC-12759
2% OPC-12759 (rebamipide) ophthalmic suspension
Placebo Comparator: placebo
placebo of OPC-12759 (rebamipide) ophthalmic suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
Time Frame: baseline, 12 weeks
FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, 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 (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.
baseline, 12 weeks
Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)
Time Frame: Baseline, 12 weeks
POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 0 is better. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.
Baseline, 12 weeks

Collaborators and Investigators

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

Investigators

  • Study Director: Satoshi Oshima, Dermatologicals & Ophthalmologicals Division

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

January 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (Estimate)

October 6, 2005

Study Record Updates

Last Update Posted (Estimate)

February 28, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

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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