Oral Nutrition Impact on Tear Film (ONIT)

March 22, 2012 updated by: Eye and Vision Technologies and Research Institute

Eight Week Feasibility Study Enrolling Dry Eye Subjects Confirmed by Four of Seven Dianostic Markers Responding to Nutritional Therapy

Dry eye disease (DED) is a common but often inadequately treated disease of the tears and surface of the eye. It can cause poor vision and chronic pain and is more frequent with increasing age. The 1995 Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye defined dry eye as "a disorder of the tear film due to tear deficiency or excessive evaporation, which causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort". The International Dry Eye Work Shop (DEWS) committee subsequently defined dry eye as "a multi-factorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface." Typically, symptoms associated with dry eye disease include ocular burning, foreign body sensation (sand or grit), photophobia (light sensitivity), and other symptoms that result in overall long term discomfort in patients. The proposed eight week feasibility study if dry eye subjects confirmed elevated osmolarity and symptoms respond to nutritional therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hyperosmolarity is a major cause of cell damage over time and can result in apoptosis of corneal and conjunctival cells. Determining if a patient has hyperosmolarity is critical allowing us to offer therapies to correct the problem. Reducing and regulating osmolarity is important in preventing potential long-term tissue compromise. Treatment leading to decreasing tear osmolarity can improve the patient's quality of life by stabilizing vision and, in many cases, simply allowing patients to return to normal activities.

Fatty Acids (EFA) have been shown to diminish inflammatory responses in many human inflammatory diseases, and interest in the use of omega-3 and omega-6 fatty acids for disease treatment has resulted in several small studies as well as the use (and over-the-counter availability) of EFA-containing nutritional supplements, including several specifically for the treatment of DED. Unfortunately, the effects of Omega 3 on dry eye disease have not been established to date. The purpose of this study is to better understand the role of Omega 3 plays in the regulating tear osmolarity in patients with established findings consistent with dry eye disease.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Conifer, Colorado, United States, 80433
        • Recruiting
        • Scot Morris
        • Contact:
        • Principal Investigator:
          • Scot Morris, O.D.
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Davis EyeCare
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert L Davis, O.D.
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Recruiting
        • Koffler Vision Group
        • Contact:
        • Contact:
          • Paul M. Karpecki, O.D.
          • Phone Number: 800-998-2068
        • Principal Investigator:
          • Bruce Koffler, M.D.
        • Sub-Investigator:
          • Paul Karpecki, O.D.
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Sean Mulqueeny OD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sean Mulqueeny, O.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 79 at the time of informed consent.
  • Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions.
  • A diagnosis of dry eye disease based on a global clinical assessment by the attending clinician, patient complaint of dry eye symptoms and osmolarity. There will be two osmolarity tiers; the lower tier is an open label design based on an average osmolarity between 316-326 mOsmo/L, and the other a group >=327 mOsmol/L. (Enrollment in the two tiers can either be simultaneous, or the second tier can be included after a responder analysis is done of tier 1).

Exclusion Criteria:

  • 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 Visit 1 or at any time during the study.
  • Ophthalmologic drop use within 2 hours of any study visits.
  • Pregnancy or lactation at any time during the study by history.
  • Abnormality of nasolacrimal drainage (by history).
  • Punctal cauterization or current punctal plug placement or within 30 days of punctual plug removal.
  • Permissible Medications/Treatments- any commercially available OTC artificial tear.
  • Prohibited Medications- Cyclosporine; any topical prescription medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical macrolides; oral nutraceuticals (flax, fish, black currant seed oils, etc...) within 3 weeks of baseline.

Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Visit 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega 3, Vitamins A, D3 and E
Dry eye patients that have been screened with elevated osmolarity dispensed EZ Tears supplements containing Omega 3, Vitamins A, D3 and E to evaluate the change in dry eye conditions subjectively and objectively.
Dietary supplement: Omega 3, Vitamins A, D3 and E
omega 3 1480 mg vitamin A 1,000 IU vitamin D3 2,000 IU vitamin E 60 IU
Other Names:
  • EZ Tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dry eye subjects ingesting omega three and the effect on seven diagnostic markers responding to omega 3 nutritional therapy.
Time Frame: two months
This multi-centre study will screen patients with dry eye disease defined by objective diagnostic procedures to include TearLab Osmolarity, Tear Break Up Time (TBUT), Corneal Staining, Conjunctival Staining, phenol red thread test, Ocular Surface Disease Index and Meniscus height. Patients will also be assessed using subjective questionnaires to document the change of comfort and vision with the addition to their diet omega 3 supplements.
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye and Vision Technologies and Research Institute

Collaborators

ZeaVision, Inc.

Investigators

  • Principal Investigator: Sean Mulqueeny, OD
  • Study Director: Robert L Davis, O.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

March 22, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-09-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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