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Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye

Primary Purpose

Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
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 Keratoconjunctivitis Sicca focused on measuring dry eye

Eligibility Criteria

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

Inclusion Criteria: have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months had intermittent or regular artificial tear use within past 3 months Exclusion Criteria: had LASIK surgery had punctal occlusion or cauterization within last 3 months

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2002
    Last Updated
    October 1, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00037661
    Brief Title
    Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye
    Official Title
    Double-Masked, Randomized, Placebo-Controlled Study of Efficacy Parameter Following Administration of INS365 Ophthalmic Solution or Placebo in a Controlled Adverse Environment (CAE) Chamber in Subjects With Non-Sjogren's Associated Dry Eye
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    March 2003 (Actual)
    Study Completion Date
    March 2003 (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
    Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconjunctivitis Sicca
    Keywords
    dry eye

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    222 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    INS365 Ophthalmic Solution

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months had intermittent or regular artificial tear use within past 3 months Exclusion Criteria: had LASIK surgery had punctal occlusion or cauterization within last 3 months

    12. IPD Sharing Statement

    Learn more about this trial

    Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye

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