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Oral Nutrition Impact on Tear Film (ONIT)

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: NCT01561040
Recruitment Status : Unknown
Verified March 2012 by Eye and Vision Technologies and Research Institute.
Recruitment status was:  Recruiting
First Posted : March 22, 2012
Last Update Posted : March 26, 2012
ZeaVision, Inc.
Information provided by (Responsible Party):
Eye and Vision Technologies and Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Dietary Supplement: Omega 3, Vitamins A, D3 and E Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Eight Week Feasibility Study Enrolling Dry Eye Subjects Confirmed by Four of Seven Dianostic Markers Responding to Nutritional Therapy
Study Start Date : March 2012
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

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 Name: EZ Tears

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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): NCT01561040

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Contact: Sean Mulqueeny, OD 314-542-3600
Contact: Robert L Davis, OD 708-636-0600

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United States, Colorado
Scot Morris Recruiting
Conifer, Colorado, United States, 80433
Contact: Scot Morris, O.D.    303-838-9165   
Principal Investigator: Scot Morris, O.D.         
United States, Illinois
Davis EyeCare Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Robert L Davis, O.D.    708-636-0600   
Contact: Brad Cogswell, O.D.    708-636-0600   
Principal Investigator: Robert L Davis, O.D.         
United States, Kentucky
Koffler Vision Group Recruiting
Lexington, Kentucky, United States, 40509
Contact: Bruce Koffler, M.D.    800-998-2068   
Contact: Paul M. Karpecki, O.D.    800-998-2068      
Principal Investigator: Bruce Koffler, M.D.         
Sub-Investigator: Paul Karpecki, O.D.         
United States, Missouri
Sean Mulqueeny OD Recruiting
Creve Coeur, Missouri, United States, 63141
Contact: Robert L Davis, OD    708-636-0600   
Contact: Scot Morris, OD    313-838-9165   
Principal Investigator: Sean Mulqueeny, O.D.         
Sponsors and Collaborators
Eye and Vision Technologies and Research Institute
ZeaVision, Inc.
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Principal Investigator: Sean Mulqueeny, OD
Study Director: Robert L Davis, O.D.
Publications of Results:
Other Publications:
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Responsible Party: Eye and Vision Technologies and Research Institute Identifier: NCT01561040    
Other Study ID Numbers: C-09-2011
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012
Keywords provided by Eye and Vision Technologies and Research Institute:
Dry Eye syndrome
tear film deficiency
Essential Fatty Acid nutritional supplements
Omega three supplements
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Vitamin D
Vitamin A
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents