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

Last updated: August 2, 2016
Sponsor: Physician Recommended Nutriceuticals
Overall Status: Completed

Phase

2/3

Condition

Sjogren's Syndrome

Dry Eyes

Eyelid Inflammation

Treatment

N/A

Clinical Study ID

NCT02260960
PRN 20142
  • Ages 18-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 and ≤ 90 at the time of informed consent

  • Subjects experiencing dry eye based on a global clinical assessment by the attendingclinician, subject complaint of dry eye symptoms

  • Presence or History of Tear Osmolarity (Appendix 2) equal to or greater than 312mOsm/L in at least one eye

  • Presence or History of Meibomian Gland Dysfunction (Grade 1 or 2) in at least one eye

Exclusion

Exclusion Criteria:

  • Allergy to fish oil or safflower oil

  • Clinically significant eyelid deformity or eyelid movement disorder that is caused byconditions such as notch deformity, incomplete lid closure, entropion, ectropion,hordeola or chalazia

  • Previous ocular disease leaving sequelae or requiring current topical eye therapyother than for DED, including, but not limited to: active corneal or conjunctivalinfection 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 atany time during the study

  • Ophthalmologic drop use within 2 hours of any study visits. Any OTC habitualartificial 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 prescriptionmedications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines ortopical macrolides; oral nutraceuticals (flax, black currant seed oils, etc…) within 3weeks (21 days) of Screening and at any time during the study

Study Design

Total Participants: 122
Study Start date:
March 01, 2014
Estimated Completion Date:
March 31, 2015

Connect with a study center

  • The Eye Center of Columbus

    Columbus, Ohio 43215
    United States

    Site Not Available

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