Oral Nutrition Impact on Tear Film (ONIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Eye and Vision Technologies and Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ZeaVision, Inc.
Information provided by (Responsible Party):
Eye and Vision Technologies and Research Institute
ClinicalTrials.gov Identifier:
NCT01561040
First received: October 25, 2011
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Dry Eye Syndrome
Dietary Supplement: Omega 3, Vitamins A, D3 and E
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eye and Vision Technologies and Research Institute:

Primary Outcome Measures:
  • Dry eye subjects ingesting omega three and the effect on seven diagnostic markers responding to omega 3 nutritional therapy. [ Time Frame: two months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561040

Contacts
Contact: Sean Mulqueeny, OD 314-542-3600 spmulqueeny@surevision.us
Contact: Robert L Davis, OD 708-636-0600 eyemanage@aol.com

Locations
United States, Colorado
Scot Morris Recruiting
Conifer, Colorado, United States, 80433
Contact: Scot Morris, O.D.    303-838-9165    smorris@eccvision.com   
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    eyemanage@aol.com   
Contact: Brad Cogswell, O.D.    708-636-0600    naticogs@hotmail.com   
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    bkoffler@aol.com   
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    eyemanage@aol.com   
Contact: Scot Morris, OD    313-838-9165    smorris@eccvision.com   
Principal Investigator: Sean Mulqueeny, O.D.         
Sponsors and Collaborators
Eye and Vision Technologies and Research Institute
ZeaVision, Inc.
Investigators
Principal Investigator: Sean Mulqueeny, OD
Study Director: Robert L Davis, O.D.
  More Information

Publications:
Responsible Party: Eye and Vision Technologies and Research Institute
ClinicalTrials.gov Identifier: NCT01561040     History of Changes
Other Study ID Numbers: C-09-2011
Study First Received: October 25, 2011
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board

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:
Vitamin A
Retinol palmitate
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Syndrome
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Disease
Pathologic Processes
Vitamins
Vitamin D
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014