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

NCT01240382 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2014-08-13

Study results available
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Summary

To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.

Conditions

  • Dry Eye

Interventions

DRUG

3% DE-089 ophthalmic solution

DRUG

0.1% sodium hyaluronate ophthalmic solution

Sponsors & Collaborators

  • Santen Pharmaceutical Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2008-02-29

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01240382 on ClinicalTrials.gov