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CompletedNCT02260960Updated Aug 4, 2016

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

A Phase 2/3 interventional study of Omega-3 (Triglyceride form) in Dry Eye Disease, sponsored by Physician Recommended Nutriceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-08-04.

Sponsored by Physician Recommended Nutriceuticals · Phase 2/3, Interventional, and Supportive care

Phase
Phase 2/3
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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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.

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Conditions studied

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In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.

This study's enrollment of 122 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Physician Recommended Nutriceuticals is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    Omega-3

    Reesterified Triglyceride form omega 3

    Dietary Supplement: Omega-3 (Triglyceride form)

  • Placebo comparator
    Placebo

    safflower oil

    Dietary Supplement: Omega-3 (Triglyceride form)

Interventions

  • Dietary supplementOmega-3 (Triglyceride form)
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What researchers measure

Primary outcomes

  1. Tear Osmolarity

    Time frame: 12 weeks

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Study locations

1 site
  • The Eye Center of Columbus
    Columbus, Ohio 43215, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02260960
Lead sponsor
Physician Recommended Nutriceuticals
Responsible party
Sponsor
First posted
Oct 9, 2014
Start date
Mar 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Aug 4, 2016

Study contacts

Alice Epitropoulos, MD
principal investigator · The Eye Center of Columbus
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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