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Oral Nutrition Impact on Tear Film (ONIT)

Primary Purpose

Dry Eye Syndrome

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Omega 3, Vitamins A, D3 and E

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye syndrome, tear film deficiency, Essential Fatty Acid nutritional supplements, Omega three supplements

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Scot MorrisRecruiting
Davis EyeCareRecruiting
Koffler Vision GroupRecruiting
Sean Mulqueeny ODRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omega 3, Vitamins A, D3 and E

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01561040

First Posted

October 25, 2011

Last Updated

March 22, 2012

Sponsor

Eye and Vision Technologies and Research Institute

Collaborators

ZeaVision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01561040

Brief Title

Oral Nutrition Impact on Tear Film

Acronym

ONIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eye and Vision Technologies and Research Institute

Collaborators

ZeaVision, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Omega 3, Vitamins A, D3 and E

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega 3, Vitamins A, D3 and E

Other Intervention Name(s)

EZ Tears

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

two months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sean Mulqueeny, OD

Phone

314-542-3600

spmulqueeny@surevision.us

First Name & Middle Initial & Last Name or Official Title & Degree

Robert L Davis, OD

Phone

708-636-0600

eyemanage@aol.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sean Mulqueeny, OD

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert L Davis, O.D.

Official's Role

Study Director

Facility Information:

Facility Name

Scot Morris

City

Conifer

State/Province

Colorado

ZIP/Postal Code

80433

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Scot Morris, O.D.

Phone

303-838-9165

smorris@eccvision.com

First Name & Middle Initial & Last Name & Degree

Scot Morris, O.D.

Facility Name

Davis EyeCare

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert L Davis, O.D.

Phone

708-636-0600

eyemanage@aol.com

First Name & Middle Initial & Last Name & Degree

Brad Cogswell, O.D.

Phone

708-636-0600

naticogs@hotmail.com

First Name & Middle Initial & Last Name & Degree

Robert L Davis, O.D.

Facility Name

Koffler Vision Group

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruce Koffler, M.D.

Phone

800-998-2068

bkoffler@aol.com

First Name & Middle Initial & Last Name & Degree

Paul M. Karpecki, O.D.

Phone

800-998-2068

First Name & Middle Initial & Last Name & Degree

Bruce Koffler, M.D.

First Name & Middle Initial & Last Name & Degree

Paul Karpecki, O.D.

Facility Name

Sean Mulqueeny OD

City

Creve Coeur

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert L Davis, OD

Phone

708-636-0600

eyemanage@aol.com

First Name & Middle Initial & Last Name & Degree

Scot Morris, OD

Phone

313-838-9165

smorris@eccvision.com

First Name & Middle Initial & Last Name & Degree

Sean Mulqueeny, O.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

20717931

Citation

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.

Results Reference

background

PubMed Identifier

20631232

Citation

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.

Results Reference

result

PubMed Identifier

18234997

Citation

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.

Results Reference

result

PubMed Identifier

20393114

Citation

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.

Results Reference

result

PubMed Identifier

20597641

Citation

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.

Results Reference

result

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Oral Nutrition Impact on Tear Film

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