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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00037661
Collaborator
(none)
222
Enrollment
11
Duration (Months)

Study Details

Study Description

Brief Summary

Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.

Condition or Disease Intervention/Treatment Phase
  • Drug: INS365 Ophthalmic Solution
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
222 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date :
Apr 1, 2002
Actual Primary Completion Date :
Mar 1, 2003
Actual Study Completion Date :
Mar 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00037661
    Other Study ID Numbers:
    • 03-108
    First Posted:
    May 20, 2002
    Last Update Posted:
    Oct 2, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Merck Sharp & Dohme LLC
    dry eye
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Keratoconjunctivitis
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Oct 2, 2015