- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01614847
Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears
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 artificial tears containing hyaluronate. 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 and dry eye status. Dry eye is usually treated with artificial tears, and many formulations are available. The investigators will test an isotonic solution that contains hyaluronate. Hyaluronate binds water and should help to maintain water on the eye.
Objective:
We plan to study the time course of possible changes in tear film osmolarity following instillation of an isotonic artificial tear containing hyaluronate. 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 isotonic hyaluronate (Blink Contacts) artificial tears relative to normal saline solution.
Hypothesis:
The investigators should be able to measure a decrease in tear osmolarity over time following instillation due to the water-binding effect of hyaluronate artificial tears relative to a control (normal saline solution).
Study Overview
Detailed Description
ABSTRACT:
Introduction: Tear hyper-osmolarity may be a fundamental cause of dry eye in many cases. Hyaluronate is an agent used in some artificial tears, which binds water and can protect against evaporation. It may therefore be an effective treatment for tear hyper-osmolarity.
Purpose: Our purpose was to measure changes in tear osmolarity over time following instillation of Blink Contacts, an isotonic ocular lubricant containing hyaluronate. We hypothesized that even in isotonic solution, the water-binding properties of hyaluronate would reduce tear osmolarity. This will help us better understand efficacy of this treatment and develop a rational basis for dosing schedules.
Methods: After baseline osmolarity measurements, eight subjects received either Blink Contacts or normal saline drops in both eyes. We re-measured osmolarity five minutes later, and then at 15-minute intervals up to 95 minutes. Subjects also rated comfort at each time. The next day, the experiment was repeated with the alternate drops for each subject.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Oklahoma
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Tahlequah, Oklahoma, United States, 74464
- Northeastern State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Normal saline
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At random, subjects will receive isotonic artificial tear or a control (normal saline).
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Experimental: Isotonic hyaluronate artificial tear
At random, subjects will receive isotonic hyaluronate artificial tear or a control (normal saline).
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At random, subjects will receive isotonic artificial tear or a control (normal saline).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Osmolarity Change From Baseline (mOsms/L) as a Function of Time (Minutes)
Time Frame: Baseline, followed by 7 measurements made after instillation (5, 20, 35, 50, 65, 80, 95 minutes post-instillation).
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Raw data: Baseline (pre-instillation) tear osmolarity was measured for right and left eyes for each subject.
Then measurements were repeated at 7 times (5, 20, 35, 50, 65 890 and 95 minutes) after instillation.
Data processing: 1) Baseline osmolarity was subtracted from each post-baseline measurement to give a change-from-baseline values.
2) Right and left eye change values averaged to give a mean osmolarity change for each subject at each of the seven times.
3) Mean osmolarity changes values were averaged across 8 subjects for each of the 7 times and entered in the table below.
Row 1 is for Drop A (hyaluronate); Row 2 for Drop B (saline).
Column are for the 7 times.
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Baseline, followed by 7 measurements made after instillation (5, 20, 35, 50, 65, 80, 95 minutes post-instillation).
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Thomas O Salmon, OD, PhD, Northeastern State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSUOCO-2012-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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