Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01382225

First received: June 9, 2011

Last updated: June 4, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 9, 2011
Last Updated Date	June 4, 2012
Start Date ^ICMJE	July 2011
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 24, 2011)	Change from baseline in lissamine green staining total score [ Time Frame: Day 7 ] [ Designated as safety issue: No ] Change from baseline in global symptom frequency total score [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01382225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to determine if sodium hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Dry Eye Syndrome
Intervention ^ICMJE	Drug: Sodium hyaluronate ophthalmic solution, 0.18% 1-2 drops in each eye, 3-6 times per day as needed Other: Vehicle 1-2 drops in each eye, 3-6 times per day as needed
Study Arm (s)	Experimental: Sodium hyaluronate ophthalmic solution, 0.18% Topical ocular drop Intervention: Drug: Sodium hyaluronate ophthalmic solution, 0.18% Placebo Comparator: Vehicle Topical ocular drop Intervention: Other: Vehicle
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1454
Completion Date	May 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Must have a documented history of dry eyes for at least 3 months Must have ocular discomfort due to dry eyes Must have presence of corneal and conjunctival staining Exclusion Criteria: Cannot wear contact lenses during the study Cannot have punctal plugs or punctal occlusion initiated within 3 months of screening Cannot have participated in another study using sodium hyaluronate, 0.18%
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 Number ^ICMJE	NCT01382225
Other Study ID Numbers ^ICMJE	C-09-045
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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