Residence Time Evaluation of Marketed OTC Ophthalmic Products

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00804791

First received: December 5, 2008

Last updated: January 31, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 5, 2008
Last Updated Date	January 31, 2012
Start Date ^ICMJE	November 2008
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 19, 2012)	Ocular Surface Residence Time [ Time Frame: After 8 minutes, then every 2 minutes ] [ Designated as safety issue: No ] Ocular surface residence time is the time for fluorescent intensity of the cornea to return to baseline measurement after installation of test article.
Original Primary Outcome Measures ^ICMJE (submitted: December 8, 2008)	residence time [ Time Frame: 8 minutes, then every 2 minutes ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00804791 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	Residence Time Evaluation of Marketed OTC Ophthalmic Products
Official Title ^ICMJE	Not Provided
Brief Summary	The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Dry Eye
Intervention ^ICMJE	Other: Systane Ultra Lubricant Eye Drops artificial tears solution for lubricating the cornea Other Name: Systane Ultra Lubricant Eye Drops Other: Unisol 4 Saline Solution saline solution for irrigating the cornea Other Name: Unisol 4 Saline Solution
Study Arm (s)	Active Comparator: Systane One drop dispensed into each eye Intervention: Other: Systane Ultra Lubricant Eye Drops Active Comparator: Unisol One drop dispensed into each eye Intervention: Other: Unisol 4 Saline Solution
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	25
Completion Date	Not Provided
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Informed consent and HIPAA read, signed and dated before conducting any procedures. Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score > or = to 5 on modified Schein questionnaire; NaFl TFBUT < or = to 7 seconds in either eye; or NaFl corneal staining sum score > or = to 3 (using 0-15 point grading system). Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU. Exclusion Criteria: History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months. History or evidence of serious ocular trauma in either eye w/i the past 6 months. History of intolerance or hypersensitivity to any component of the study medications. History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye. Use of concomitant topical ocular medications during the study period. Patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1, and the dosing regimen must remain stable throughout the study period. Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article. Individuals unwilling to d/c contact lens wear during the study period. CL wear must have been d/c at least one week prior to Visit 1. Participation in an investigational drug or device study w/i 30 days of entering this study. Additionally, any subject may be declared ineligible for a valid medical reason.
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	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00804791
Other Study ID Numbers ^ICMJE	M-08-11
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	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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