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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT02260960

Run by

Physician Recommended Nutriceuticals

People needed

122

Starts

2014-03-01

Expected to finish

2015-03-01

Last updated by the study team

2016-08-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Eye Center of Columbus — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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