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

Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Age Range:18 - 90
Start Date:March 2014
Contact:Alice Epitropoulos, MD

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

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.

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
We found this trial at
Columbus, Ohio 43215
Columbus, OH
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