Allergic Conjunctivitis
Conditions
Keywords
tears, conjunctival epithelial cells, olopatadine, eosinophils
Brief summary
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.
Detailed description
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.
Interventions
DRUGolopatadine
olopatadine one drop in one eye for one week
Sponsors
National Eye Institute (NEI)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Skin test positive * Able to put drops in eyes * Able to have tears collected
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 week for tear collection, tears stored at - 80 C until used | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Olopatadine Treatment (Only One Eye) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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.
Time frame: 1 week for tear collection, tears stored at - 80 C until used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tears From Olopatadine Treated Eyes | 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 | 4517 eosinophils/square cm epithelial cells | Standard Error 485 |
| Tears From Untreated Eyes | 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 | 5004 eosinophils/square cm epithelial cells | Standard Error 445 |
Comparison: tears were collected in season from eyes of allergic patients with or without olopatadine treatment, that is one eye was treated and the patients other eye was not.~Tears from each patient's eyes were pooled to provide enough volume.p-value: <0.05ANOVA