The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease

Study Overview
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Brief Summary
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The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity, Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared to administration of placebo.

Official Title
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The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease.

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Dietary Supplement: Omega-3 (Triglyceride form)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and ≤ 90 at the time of informed consent Subjects experiencing dry eye based on a global clinical assessment by the attending clinician, subject complaint of dry eye symptoms Presence or History of Tear Osmolarity (Appendix 2) equal to or greater than 312 mOsm/L in at least one eye Presence or History of Meibomian Gland Dysfunction (Grade 1 or 2) in at least one eye Exclusion Criteria: Allergy to fish oil or safflower oil Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring Active ocular or nasal allergy LASIK or PRK surgery that was performed within one year of the Screening Visit or at any time during the study Ophthalmologic drop use within 2 hours of any study visits. Any OTC habitual artificial tear should be continued at the same frequency and no change in drop brand Contact lens wear within 12 hours of any study visits Pregnancy or lactation during the study Abnormal nasolacrimal drainage (by history) Punctal cauterization or punctal plug placement within 60 days of screening Prohibited Medications - Cyclosporine (Restasis®); any topical prescription medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical macrolides; oral nutraceuticals (flax, black currant seed oils, etc…) within 3 weeks (21 days) of Screening and at any time during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3<br>Reesterified Triglyceride form omega 3 | Dietary Supplement: Omega-3 (Triglyceride form)<br> <br> |
| Placebo Comparator: Placebo<br>safflower oil | Dietary Supplement: Omega-3 (Triglyceride form)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Osmolarity |  | 12 weeks |