Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: September 26, 2014
Last verified: September 2014

May 18, 2002
September 26, 2014
April 2002
March 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00037661 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Keratoconjunctivitis Sicca
Drug: INS365 Ophthalmic Solution
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
March 2003
March 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00037661
03-108
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP