Oral Nutrition Impact on Tear Film

NCT01561040 | Unknown Phase 4

• 1 other identifier: C-09-2011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Dry Eye Syndrome

Keywords

Dry Eye syndrome; tear film deficiency; Essential Fatty Acid nutritional supplements; Omega three supplements

Outcome Measures

Primary Outcomes (1)

• Dry eye subjects ingesting omega three and the effect on seven diagnostic markers responding to omega 3 nutritional therapy.

  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

Study Arms (1)

Omega 3, Vitamins A, D3 and E

EXPERIMENTAL

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

Interventions

Omega 3, Vitamins A, D3 and E DIETARY_SUPPLEMENT

omega 3 1480 mg vitamin A 1,000 IU vitamin D3 2,000 IU vitamin E 60 IU

Also known as: EZ Tears

Omega 3, Vitamins A, D3 and E

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye and Vision Technologies and Research Institute: lead
• ZeaVision, Inc.: collaborator

Study Sites (4)

Scot Morris

Conifer, Colorado, 80433, United States

RECRUITING

Davis EyeCare

Oak Lawn, Illinois, 60453, United States

RECRUITING

Koffler Vision Group

Lexington, Kentucky, 40509, United States

RECRUITING

Sean Mulqueeny OD

Creve Coeur, Missouri, 63141, United States

RECRUITING

Related Publications (5)

• Png E, Samivelu GK, Yeo SH, Chew J, Chaurasia SS, Tong L. Hyperosmolarity-mediated mitochondrial dysfunction requires Transglutaminase-2 in human corneal epithelial cells. J Cell Physiol. 2011 Mar;226(3):693-9. doi: 10.1002/jcp.22389.

  PMID: 20717931 BACKGROUND

• Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.

  PMID: 20631232 RESULT

• Chen Z, Tong L, Li Z, Yoon KC, Qi H, Farley W, Li DQ, Pflugfelder SC. Hyperosmolarity-induced cornification of human corneal epithelial cells is regulated by JNK MAPK. Invest Ophthalmol Vis Sci. 2008 Feb;49(2):539-49. doi: 10.1167/iovs.07-0569.

  PMID: 18234997 RESULT

• Suzuki M, Massingale ML, Ye F, Godbold J, Elfassy T, Vallabhajosyula M, Asbell PA. Tear osmolarity as a biomarker for dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Sep;51(9):4557-61. doi: 10.1167/iovs.09-4596. Epub 2010 Apr 14.

  PMID: 20393114 RESULT

• Versura P, Profazio V, Campos EC. Performance of tear osmolarity compared to previous diagnostic tests for dry eye diseases. Curr Eye Res. 2010 Jul;35(7):553-64. doi: 10.3109/02713683.2010.484557.

  PMID: 20597641 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Sean Mulqueeny, OD

  PRINCIPAL INVESTIGATOR

• Robert L Davis, O.D.

  STUDY DIRECTOR

Central Study Contacts

Sean Mulqueeny, OD

CONTACT

314-542-3600; spmulqueeny@surevision.us

Robert L Davis, OD

CONTACT

708-636-0600; eyemanage@aol.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: March 22, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

US (4)