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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY012526 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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The purpose of the research is to determine which inflammatory substances are involved in causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances released by cells in the affected tissues cause allergic reactions in the eye and elsewhere in the body.
Ocular allergies are extremely common, affecting up to 80 million people in the USA. Our research question is:
Are there differences in inflammatory mediators and cell surface activation markers in patients undergoing seasonal allergic conjunctivitis compared to those with sight threatening disease such as Atopic Keratoconjunctivitis (AKC) and will the use of the anti-allergy eye drop, PATANOL® (olopatadine hydrochloride) affect these parameters?
Experimental Design:
Ocular surface cells (by impression cytology) and tears (via capillary tube) are collected from allergic, non-allergic, and AKC subjects undergoing an reaction induced either by seasonal allergen or topical allergen provocation (specificity and dose determined via skin testing). Ocular surface cells are evaluated for surface activation markers. Tears are evaluated for mediator content. Tears are also incubated with peripheral blood eosinophils and lymphocytes to see effects on adhesion to conjunctival epithelial cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olopatadine | Experimental | one drop in one eye only two times per day at an interval of 6 to 8 hours for 1 week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olopatadine | Drug | olopatadine one drop in one eye for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study Examined Whether the Incubation of Human Conjunctival Epithelial Cells With Tears Pooled From Allergic Subjects (One Eye With and Other Eye Without Olopatadine Treatment) Promotes Eosinophil Adhesion | Outcome: The collected tears (from 10 subjects)were pooled, incubated with primary conjunctival epithelial cells before eosinophil adhesion was measured via eosinophil peroxidase assay. Eosinophils in eosinophils / square cm measured. | 1 week for tear collection, tears stored at - 80 C until used |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal P Barney, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15349046 | Background | Cook EB. Tear cytokines in acute and chronic ocular allergic inflammation. Curr Opin Allergy Clin Immunol. 2004 Oct;4(5):441-5. doi: 10.1097/00130832-200410000-00018. | |
| 16877412 | Result | Cook EB, Stahl JL, Brooks AM, Graziano FM, Barney NP. Allergic tears promote upregulation of eosinophil adhesion to conjunctival epithelial cells in an ex vivo model: inhibition with olopatadine treatment. Invest Ophthalmol Vis Sci. 2006 Aug;47(8):3423-9. doi: 10.1167/iovs.06-0088. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Olopatadine | one drop olopatadine in one eye only, two times per day at an interval of 6 to 8 hours for 1 week. This allows the untreated eye to be the control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Olopatadine Treatment (Only One Eye) | one drop olopatadine in one eye only, two times per day at an interval of 6 to 8 hours for 1 week. This allows the untreated eye to be the control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Study Examined Whether the Incubation of Human Conjunctival Epithelial Cells With Tears Pooled From Allergic Subjects (One Eye With and Other Eye Without Olopatadine Treatment) Promotes Eosinophil Adhesion | Outcome: The collected tears (from 10 subjects)were pooled, incubated with primary conjunctival epithelial cells before eosinophil adhesion was measured via eosinophil peroxidase assay. Eosinophils in eosinophils / square cm measured. | Posted | Mean | Standard Error | eosinophils/square cm epithelial cells | 1 week for tear collection, tears stored at - 80 C until used |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olopatadine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jim Stahl, PhD | University of Wisconsin-Madison | 608-263-6177 | jlstahl@wisc.edu |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | tears were collected from olopatadine treated eye and untreated eye of participants . tears were collected from 21 participants ( not 42) not all collected tears were used in final experiments. | Number | participants |
|
| OG001 | Tears From Untreated Eyes | Allergic subjects treated one eye with olopatadine and did not treat other eye (control). Tears collected from both eyes and incubated with conjunctival epithelial cells. We determined whether tears collected from olopatadine treated eyes of subjects result in more or less purified peripheral blood eosinophil adhesion to conjunctival epithelial cells compared to tears collected from untreated eyes from the same subjects. |
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| 0 |
| 21 |
| 0 |
| 21 |
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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| D014947 | Wounds and Injuries |