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

This study has been completed.
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01240382
First received: November 12, 2010
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dry Eye
 Drug: 3% DE-089 ophthalmic solution
Drug: 0.1% sodium hyaluronate ophthalmic solution
 Phase 3

Study Type: Interventional
Official Title: Double-masked Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Multi-center Study, in Comparison to 0.1% Sodium Hyaluronate Ophthalmic Solution) - Phase III Confirmatory Study -

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santen Pharmaceutical Co., Ltd.:

Arms Assigned Interventions
Experimental: 3% DE-089 Drug: 3% DE-089 ophthalmic solution
Active Comparator: 0.1% HA Drug: 0.1% sodium hyaluronate ophthalmic solution

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240382

Locations
Japan
Santen study sites
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
  More Information

No publications provided by Santen Pharmaceutical Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01240382     History of Changes
Other Study ID Numbers: 00890602
Study First Received: November 12, 2010
Last Updated: November 12, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
 Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013