Status:
COMPLETED
The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease
Lead Sponsor:
Physician Recommended Nutriceuticals
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
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 te...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT02260960
Start Date
March 1 2014
End Date
March 1 2015
Last Update
August 4 2016
Active Locations (1)
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1
The Eye Center of Columbus
Columbus, Ohio, United States, 43215