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

NCT02260960 | Completed Phase 2

• 1 other identifier: PRN 20142
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Tear Osmolarity

  12 weeks

Study Arms (2)

Omega-3

EXPERIMENTAL

Reesterified Triglyceride form omega 3

Dietary Supplement: Omega-3 (Triglyceride form)

Placebo

PLACEBO COMPARATOR

safflower oil

Dietary Supplement: Omega-3 (Triglyceride form)

Interventions

Omega-3 (Triglyceride form) DIETARY_SUPPLEMENT

Omega-3; Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Physician Recommended Nutriceuticals: lead

Study Sites (1)

The Eye Center of Columbus

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Alice Epitropoulos, MD

  The Eye Center of Columbus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

US (1)