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A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
diquafosol tetrasodium (INS365) ophthalmic solution
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Inclusion Criteria:

  • Best corrected visual acuity of at least +0.7 ETDRS
  • Six month history of dry eye disease
  • Mild severity in two out of five symptoms
  • Unanesthetized Schirmer score of less than or equal to 7mm
  • Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18

Exclusion Criteria:

  • Nasal stimulated Schirmer score of less than 3mm
  • Have ongoing ocular infection
  • Have congenitally absent meibomian or lacrimal glands
  • Have had punctal occlusion within a specified time prior to study
  • Wear contact lens and refuse to remove them
  • Have other excluded eye conditions.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Schirmer scores
    Corneal staining
    Conjunctival staining
    Tear break-up time
    Change in artificial tear usage
    Patient-reported improvement of foreign body sensation

    Secondary Outcome Measures

    Visual acuity
    Investigator global severity assessment
    Patient-reported dry eye symptoms other than foreign body sensation
    Biomicroscopy
    Ophthalmoscopy
    IOP

    Full Information

    First Posted
    May 15, 2008
    Last Updated
    August 26, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00679718
    Brief Title
    A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease
    Official Title
    A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Patients With Moderate to Severe Dry Eye Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2000 (undefined)
    Primary Completion Date
    July 2000 (Actual)
    Study Completion Date
    July 2000 (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
    To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe 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 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    diquafosol tetrasodium (INS365) ophthalmic solution
    Primary Outcome Measure Information:
    Title
    Schirmer scores
    Title
    Corneal staining
    Title
    Conjunctival staining
    Title
    Tear break-up time
    Title
    Change in artificial tear usage
    Title
    Patient-reported improvement of foreign body sensation
    Secondary Outcome Measure Information:
    Title
    Visual acuity
    Title
    Investigator global severity assessment
    Title
    Patient-reported dry eye symptoms other than foreign body sensation
    Title
    Biomicroscopy
    Title
    Ophthalmoscopy
    Title
    IOP

    10. Eligibility

    Eligibility Criteria
    Inclusion Criteria: Best corrected visual acuity of at least +0.7 ETDRS Six month history of dry eye disease Mild severity in two out of five symptoms Unanesthetized Schirmer score of less than or equal to 7mm Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18 Exclusion Criteria: Nasal stimulated Schirmer score of less than 3mm Have ongoing ocular infection Have congenitally absent meibomian or lacrimal glands Have had punctal occlusion within a specified time prior to study Wear contact lens and refuse to remove them Have other excluded eye conditions.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

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