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| Name | Class |
|---|---|
| ZeaVision, Inc. | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Mulqueeny, OD | Contact | 314-542-3600 | spmulqueeny@surevision.us | |
| Robert L Davis, OD | Contact | 708-636-0600 | eyemanage@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Sean Mulqueeny, OD | Principal Investigator | |
| Robert L Davis, O.D. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scot Morris | Recruiting | Conifer | Colorado | 80433 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20717931 | Background | 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. | |
| 20631232 | Result | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 17, 2018 | |
| Reset | Jan 25, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 17, 2018 | Jan 25, 2019 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Davis EyeCare | Recruiting | Oak Lawn | Illinois | 60453 | United States |
|
| Koffler Vision Group | Recruiting | Lexington | Kentucky | 40509 | United States |
|
| Sean Mulqueeny OD | Recruiting | Creve Coeur | Missouri | 63141 | United States |
|
| 18234997 | 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. |
| 20393114 | 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. |
| 20597641 | 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. |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |