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 -

Santen Pharmaceutical Co., Ltd.2 sites in 2 countries400 target enrollmentFebruary 2010

ConditionsDry Eye

Interventionsdiquafosol ophthalmic solution 0.1% sodium hyaluronate ophthalmic solution.

Drugsdiquafosol ophthalmic solution 0.1% sodium hyaluronate ophthalmic solution.

Overview

Phase: Not Applicable
Intervention: diquafosol ophthalmic solution
Conditions: Dry Eye
Sponsor: Santen Pharmaceutical Co., Ltd.
Enrollment: 400
Locations: 2
Primary Endpoint: Changes in the fluorescein and rose bengal staining score
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

April 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santen Pharmaceutical Co., Ltd.

Eligibility Criteria

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

Arms & Interventions

DE-089

DE-089 ophthalmic solution

Intervention: diquafosol ophthalmic solution

DE-089

DE-089 ophthalmic solution

Intervention: 0.1% sodium hyaluronate ophthalmic solution.

HA

0.1% sodium hyaluronate ophthalmic solution

Intervention: 0.1% sodium hyaluronate ophthalmic solution.

Outcomes

Primary Outcomes

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)