Changes in Tear Osmolarity After Instillation of Hypo-osmotic Artificial Tears

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Thomas O. Salmon, OD, PhD, Northeastern State University

ClinicalTrials.gov Identifier:

NCT01614847

First received: June 6, 2012

Last updated: June 7, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 6, 2012
Last Updated Date	June 7, 2012
Start Date ^ICMJE	June 2012
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 7, 2012)	Osmolarity (mOsms/L) as a function of time (minutes) [ Time Frame: Approximately 1 hours post instillation ] [ Designated as safety issue: No ] Following instillation of artificial tears, we will collect a 50-nl sample of tears using the TearLab device, which will report osmolarity of the tear film. We will measure every 15 minutes following instillation, for up to 2 hours.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01614847 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	Changes in Tear Osmolarity After Instillation of Hypo-osmotic Artificial Tears
Official Title ^ICMJE	Changes in Tear Osmolarity After Instillation of Hypo-osmotic Artificial Tears
Brief Summary	Background Osmolarity is defined as the concentration of particles dissolved in a solution. Normal tears contain various dissolved particles including proteins, salts and other electrolytes. The investigators plan to investigate how osmolarity of the tear film changes over time after instillation of hypo-osmotic artificial tears. This is one kind of artificial tear that is used to treat dry eye. Dry eye and tear osmolarity Dry eye is a significant health problem, but diagnosis and treatment are often ambiguous and ineffective. There has been a resurgence of interest and research in dry eye in the past 5 years, and tear osmolarity has emerged as perhaps, one of the most effective ways to evaluate tear quality dry eye status. Dry eye is usually treated with artificial tears, and many formulations are available. The investigators will test a hypo-osmotic solution that is designed to reduce excess osmolarity and restore a normal, healthy balance. Objective The investigators objective is to study the longevity of the hypo-osmotic effect by measuring changes in tear osmolarity as a function of time following instillation. The investigators will use the TearLab, a new clinical instrument that has been developed to quickly and easily measure tear film osmolarity. Understanding how artificial tears affect tear film osmolarity over time can help doctors determine efficacy and dosing schedules. The investigators will test the hypo-osmotic artificial tears relative to normal saline solution. Hypothesis The investigators will be able to measure hypo-osmotic artificial tear's longevity relative to a control (normal saline solution).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Dry Eye
Intervention ^ICMJE	Drug: Artificial tears At random, subjects will receive hypo-osmolar artificial tear or a control (normal saline).
Study Arm (s)	Experimental: Hypo-osmolar artificial tear At random, subjects will receive hypo-osmolar artificial tear or a control (normal saline). Intervention: Drug: Artificial tears Placebo Comparator: Normal saline Intervention: Drug: Artificial tears
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	Active, not recruiting
Estimated Enrollment ^ICMJE	12
Estimated Completion Date	June 2012
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: At least 18 years of age Normal vision in both eyes (20/30 best corrected) Preference for patient with dry eye symptoms Exclusion Criteria: No ocular disease other than dry eye Currently taking no ocular or systemic medications that might affect results
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01614847
Other Study ID Numbers ^ICMJE	NSUOCO-2012-11
Has Data Monitoring Committee	No
Responsible Party	Thomas O. Salmon, OD, PhD, Northeastern State University
Study Sponsor ^ICMJE	Thomas O. Salmon, OD, PhD
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Northeastern State University
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top