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

Sponsor
Santen Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01101984
Collaborator
(none)
400
Enrollment
2
Locations
2
Arms
26
Duration (Months)
200
Patients Per Site
7.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: diquafosol ophthalmic solution
  • Drug: 0.1% sodium hyaluronate ophthalmic solution.
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
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 -
Study Start Date :
Feb 1, 2010
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Changes in the fluorescein and rose bengal staining score [2 weeks and 4 weeks from baseline.]

      Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority) Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)

    Secondary Outcome Measures

    1. Changes in tear film breakup time (second) [2 weeks and 4 weeks from baseline.]

      Changes in tear film breakup time (second) 2 weeks, 4 week after the study / at the discontinuation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Eye & Ear Hospital of Fudan University Shanghai China 200032
    2 Singapore Eye Research Institute Singapore Singapore 168751

    Sponsors and Collaborators

    • Santen Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01101984
    Other Study ID Numbers:
    • 08901
    First Posted:
    Apr 12, 2010
    Last Update Posted:
    Nov 14, 2012
    Last Verified:
    Nov 1, 2012
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Pharmaceutical Solutions
    Ophthalmic Solutions
    Hyaluronic Acid

    Study Results

    No Results Posted as of Nov 14, 2012