A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN)

Study Overview
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Brief Summary
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Dry eye is a very common condition that most often affects women and the elderly, and can be caused when the eyes do not produce enough tears, or when the tears evaporate too quickly. Although there isn't a simple cure for dry eye, there are numerous products on the market that attempt to help relieve some of the discomfort caused by this condition. Some of these products include artificial tears, omega-3 supplements, and/or anti-inflammatory medications. The purpose of this study is to evaluate the performance of a combination of TheraTears® products, and to compare them with the product(s) you have been using.

Official Title
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A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: TheraTears® Lubricant Eye Drop
* Drug: TheraTears® preservative-free single-use containers
* Dietary Supplement: TheraTears® Nutrition
* Other: TheraTears® TheraLid® Eyelid Cleanser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is between 18 and 65 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Exhibits symptoms of dry eye for at least 3 months; Has an OSDI score of ≥ 23; Is currently on a non-omega 3 dry eye treatment regimen that, at the minimum consists of instilling artificial tears at least once a day for the past 3 months; Has an average non-invasive tear breakup time ≤ 5.00 seconds in at least one eye. Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/or infection and/or allergies; * For the purposes of study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are typical findings and are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrollment, as determined verbally; Is aphakic; Has undergone refractive error surgery; Has taken part in another (pharmaceutical) research study within the last 30 days; Has worn contact lenses within the past 5 years; Is currently using or have used omega 3 supplements in the past 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants randomized to the control group will be allowed to continue using their habitual artificial tears, and / or additional habitual concurrent dry eye treatments. | |
| Experimental: Treatment<br>Participants in the study treatment group will receive all four products: TheraTears® Lubricant Eye Drop (15mL) - Dosage: Ophthalmic, 1 or 2 drops, prn TheraTears® preservative-free single-use containers (32-pack, 0.6mL each) - Dosage: Ophthalmic, 1 or 2 drops, prn TheraTears® Nutrition (90 pack) - Dosage: Oral, 3 capsules QD TheraTears® TheraLid® Eyelid Cleanser (48mL) - Dosage: Ophthalmic, 1 or 2 application OU, QD | Drug: TheraTears® Lubricant Eye Drop<br> <br> Drug: TheraTears® preservative-free single-use containers<br> <br> Dietary Supplement: TheraTears® Nutrition<br> <br> Other: TheraTears® TheraLid® Eyelid Cleanser<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time of OSDI score | Ocular Surface Disease Index (OSDI) questionnaire score | At screening, 2 weeks, 1 month and 3 months | 
| Change over time of Visual analogue scores |  | At screening, 2 weeks, 1 month and 3 months | 
| Change over time of Tear osmolarity |  | At screening, 1 month and 3 months | 
| Change over time of Tear film breakup time |  | At screening, 1 month and 3 months | 
| Change over time of Corneal staining |  | At screening, 1 month and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time of Lid wiper epitheliopathy |  | At screening, 1 month and 3 months | 
| Change over time of Meibomian gland expressibility |  | At screening, 1 month and 3 months | 
| Change over time of Meibum quality |  | At screening, 1 month and 3 months | 
| Change over time of Tear film lipid layer thickness |  | At screening, 1 month and 3 months | 
| Change over time of Tear meniscus height |  | At screening, 1 month and 3 months | 
| Change over time of Schirmer's I scores |  | At screening, 1 month and 3 months |