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The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Diquafosol tetrasodium ophthalmic solution, 2%
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have best corrected visual acuity in both eyes of at least +0.7 or better
  • Central corneal staining of 3 on the NEI scale
  • If female, are non-pregnant or non-lactating
  • Have a history of dry eye disease in both eyes
  • Have normal lid anatomy

Exclusion Criteria:

  • Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
  • Have had ocular surface surgery within the past year
  • Are considered legally blind in one eye
  • Have a serious medical condition which could confound study assessments

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Arm 2

    Arm 1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders.

    Secondary Outcome Measures

    Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale)

    Full Information

    First Posted
    January 27, 2009
    Last Updated
    December 21, 2014
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00831662
    Brief Title
    The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    490 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 2
    Arm Type
    Placebo Comparator
    Arm Title
    Arm 1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Diquafosol tetrasodium ophthalmic solution, 2%
    Intervention Description
    One to two drops in each eye QID for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    One to two drops in each eye QID for 6 weeks
    Primary Outcome Measure Information:
    Title
    Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale)
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have best corrected visual acuity in both eyes of at least +0.7 or better Central corneal staining of 3 on the NEI scale If female, are non-pregnant or non-lactating Have a history of dry eye disease in both eyes Have normal lid anatomy Exclusion Criteria: Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study Have had ocular surface surgery within the past year Are considered legally blind in one eye Have a serious medical condition which could confound study assessments
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Reza Haque, MD, PhD
    Organizational Affiliation
    Medical Monitor, Inspire
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15502479
    Citation
    Tauber J, Davitt WF, Bokosky JE, Nichols KK, Yerxa BR, Schaberg AE, LaVange LM, Mills-Wilson MC, Kellerman DJ. Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye. Cornea. 2004 Nov;23(8):784-92. doi: 10.1097/01.ico.0000133993.14768.a9. Erratum In: Cornea. 2007 May;26(4):514.
    Results Reference
    result

    Learn more about this trial

    The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)

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