Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

November 11, 2012 updated by: Santen Pharmaceutical Co., Ltd.

A Randomized, Parallel- Group Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Comparison With 0.1% Sodium Hyaluronate Ophthalmic Solution) - A Multinational Study -

Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

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

  • China
      • Shanghai, China, 200032
        • Eye & Ear Hospital of Fudan University
  • Singapore
      • Singapore, Singapore, 168751
        • Singapore Eye Research Institute

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

21 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those who show:

    • Keratoconjunctival disorder confirmed with vital dye staining
    • Abnormal Schirmer score results

Exclusion Criteria:

  • Eye disease that needs therapy other than that for dry eye
  • Those who need to wear contact lenses during the clinical study

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: DE-089
DE-089 ophthalmic solution
Drug: diquafosol ophthalmic solution
DE-089 topical ocular application, 6 times daily for 4 weeks.
Other Names:
  • HA
Drug: 0.1% sodium hyaluronate ophthalmic solution.
0.1% HA topical ocular application, 6 times daily for 4 weeks.
Active Comparator: HA
0.1% sodium hyaluronate ophthalmic solution
Drug: 0.1% sodium hyaluronate ophthalmic solution.
0.1% HA topical ocular application, 6 times daily for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the fluorescein and rose bengal staining score
Time Frame: 2 weeks and 4 weeks from baseline.
  1. Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority)
  2. Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)
2 weeks and 4 weeks from baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in tear film breakup time (second)
Time Frame: 2 weeks and 4 weeks from baseline.
Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation
2 weeks and 4 weeks from baseline.

Collaborators and Investigators

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

Sponsor

Santen Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2010

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 7, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 11, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08901

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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