Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease - Tabular View

Tracking Information
First Received Date ^ICMJE	November 22, 2006
Last Updated Date	November 24, 2006
Start Date ^ICMJE	June 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: November 24, 2006)	Change in dry eye testing measures
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00403975 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 24, 2006)	Change in dry eye testing measures and symptoms
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease
Official Title ^ICMJE	A Multi-Center, Parallel Group, Double-Masked, Randomized, Placebo-Controlled Study of Multiple Ocular Instillations of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease
Brief Summary	The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects with mild to moderate dry eye disease.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Dry Eye Disease
Intervention ^ICMJE	Drug: diquafosol tetrasodium ophthalmic solution, 2%
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	520
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: best corrected visual acuity in both eyes of at least +0.7 six-month documented history of dry eye disease as least mild severity in 1 of the 5 dry eye symptoms corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6 (out of 15) Exclusion Criteria: permanent conjunctival goblet cell loss or scarring conditions ongoing contact lens wear current topical ophthalmic medication use
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	NCT00403975
Responsible Party
Study ID Numbers ^ICMJE	03-109
Study Sponsor ^ICMJE	Inspire Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Inspire Pharmaceuticals
Verification Date	November 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP