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

Tracking Information
First Received Date ^ICMJE	May 18, 2002
Last Updated Date	October 1, 2008
Start Date ^ICMJE	April 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00037661 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye
Official Title ^ICMJE	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
Brief Summary	Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Keratoconjunctivitis Sicca
Intervention ^ICMJE	Drug: INS365 Ophthalmic Solution
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	200
Completion Date	March 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00037661
Responsible Party
Study ID Numbers ^ICMJE	03-108
Study Sponsor ^ICMJE	Inspire Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Inspire Pharmaceuticals
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP