Dry Eye Disease
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTOmega-3 (Triglyceride form)
Sponsors
Physician Recommended Nutriceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Osmolarity | 12 weeks |
Countries
United States
Outcome results
None listed