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

NCT ID: NCT02260960

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Dry Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Omega-3

Reesterified Triglyceride form omega 3

Group Type: EXPERIMENTAL

Omega-3 (Triglyceride form)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

safflower oil

Group Type: PLACEBO_COMPARATOR

Omega-3 (Triglyceride form)

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Omega-3 (Triglyceride form)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Physician Recommended Nutriceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice Epitropoulos, MD

Role: PRINCIPAL_INVESTIGATOR

The Eye Center of Columbus

Locations

The Eye Center of Columbus

Columbus, Ohio, United States

Countries

United States

Other Identifiers

PRN 20142

Identifier Type: -

Identifier Source: org_study_id