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Trial record 47 of 8754 for:    Eye AND Eye Diseases

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02260960
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : August 4, 2016
Information provided by (Responsible Party):
Physician Recommended Nutriceuticals

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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Dietary Supplement: Omega-3 (Triglyceride form) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease.
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Tear Osmolarity [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02260960

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United States, Ohio
The Eye Center of Columbus
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Physician Recommended Nutriceuticals
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Principal Investigator: Alice Epitropoulos, MD The Eye Center of Columbus

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Responsible Party: Physician Recommended Nutriceuticals Identifier: NCT02260960     History of Changes
Other Study ID Numbers: PRN 20142
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases