Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2012-03-31
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
79 Years
ALL
Yes
Sponsors
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ZeaVision, Inc.
INDUSTRY
Eye and Vision Technologies and Research Institute
NETWORK
Responsible Party
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Principal Investigators
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Sean Mulqueeny, OD
Role: PRINCIPAL_INVESTIGATOR
Robert L Davis, O.D.
Role: STUDY_DIRECTOR
Locations
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Scot Morris
Conifer, Colorado, United States
Davis EyeCare
Oak Lawn, Illinois, United States
Koffler Vision Group
Lexington, Kentucky, United States
Sean Mulqueeny OD
Creve Coeur, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Paul M. Karpecki, O.D.
Role: backup
References
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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.
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.
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.
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.
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.
Other Identifiers
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C-09-2011
Identifier Type: -
Identifier Source: org_study_id
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