Changes in Tear Osmolarity Over Time With Sustained Use of TheraTears

Study Overview
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Brief Summary
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The objective of the study is to see if there is a change in tear osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears® lubricating drops.

Detailed Description
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The hypothesis is that the measured tear osmolarity from study participants decrease with sustained use of a over-the-counter artificial tears, TheraTears® lubricating drops, over an eight week period. Participant's dry eye symptoms would also improve with sustained use of TheraTears® lubricating drops.

Official Title
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Evaluation of Tear Osmolarity Over Time With Sustained Use of TheraTears Lubricating Drops

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Other: TheraTears lubricating drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 21 years of age and has full legal capacity to volunteer; Has read and signed the information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye; Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye. Exclusion Criteria: Has taken part in another research study within the last 30 days; Planned contact lens wear during the course of the study; Staff at the investigational site or family member of site staff or family member of currently enrolled participant; Any subject that violates the washout period by using eye drops during the 72hrs washout period; Has any known ocular disease including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome; Used Restasis (or similar topical medication) within the last 6 months; Has a systemic condition that in the opinion of the investigator may affect the dry eye status of the subject, especially those newly diagnosed, newly prescribed and/or unstable; Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary); Use of medications such as: Systemic Antihistamine (e.g., Allegra®, Benadryl®, Claritin®, Dimetapp®, Unisom®, Zyrtec®, etc.), Isotretinoin (e.g., Accutane®, Roaccutane®, Amnesteem®, Claravis®, Isotroin®, Sotret®) or similar medications; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Has undergone ocular surgery(LASIK, Cataract, etc)within the last year.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TheraTears lubricating drops<br>TheraTears lubricating eye drops to be used 1 drop in both eyes four times a day (QID) | Other: TheraTears lubricating drops<br>* A over-the-counter lubricating eye drop to be used 1 drop in both eyes 4 times a day (QID) for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tear osmolarity |  | Baseline and 8 weeks | 
| Change in the Ocular Surface Disease Index (OSDI) score | The OSDI is a questionnaire that the subject completes to gauge their dry eye symptoms. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity |  | Baseline and 8 weeks | 
| Change in Tear Break Up Time |  | baseline and 8 weeks | 
| Change in Phenol Red Thread test |  | baseline and 8 weeks | 
| Change in corneal and conjunctival staining |  | baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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keratitis sicca, tear osmolarity, ocular surface disease, TheraTears