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

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ClinicalTrials.gov Identifier: NCT00037661
Recruitment Status : Completed
First Posted : May 20, 2002
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: INS365 Ophthalmic Solution Phase 3

Study Type : Interventional  (Clinical Trial)
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 : April 2002
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00037661     History of Changes
Other Study ID Numbers: 03-108
First Posted: May 20, 2002    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:
dry eye

Additional relevant MeSH terms:
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions