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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00037661
First received: May 18, 2002
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Keratoconjunctivitis Sicca
Drug: INS365 Ophthalmic Solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Enrollment: 222
Study Start Date: April 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037661

Locations
United States, Massachusetts
Ophthalmic Research Associates, Inc.
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00037661     History of Changes
Other Study ID Numbers: 03-108
Study First Received: May 18, 2002
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014