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

Physician Recommended Nutriceuticals

Status and phase

Completed

Phase 3

Phase 2

Conditions

Dry Eye Disease

Treatments

Dietary Supplement: Omega-3 (Triglyceride form)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02260960

PRN 20142

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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