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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 18, 2002
Last updated: October 1, 2015
Last verified: October 2015
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)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00037661     History of Changes
Other Study ID Numbers: 03-108 
Study First Received: May 18, 2002
Last Updated: October 1, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Corneal Diseases
Eye Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions processed this record on May 30, 2016