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Management of Ocular Allergy Itch With an Antihistamine-Releasing Contact Lens.

ABSTRACT: PURPOSE:A contact lens (CL)-based drug delivery system for therapeutic delivery of the antihistamine ketotifen was tested in 2 parallel, conjunctival allergen challenge-based trials. METHODS:Both trials employed the same multicenter, randomized, placebo-controlled protocol. Test lenses were etafilcon A with 0.019 mg ketotifen; control lenses were etafilcon A with no added drug. Subjects were randomized into 3 treatment groups. Group 1 received test lens in one eye and control lens in the contralateral eye; the eye chosen to receive test lens was randomly selected in a 1:1 ratio. Group 2 received test lenses bilaterally, and group 3 received control lenses bilaterally. Allergen challenges were conducted on 2 separate visits: following lens insertion, the subjects were challenged at 15 minutes (to test onset) and 12 hours (to test duration). The primary endpoint was ocular itching measured using a 0 to 4 scale with half-unit steps. Secondary endpoints included ciliary, conjunctival, and episcleral hyperemia. RESULTS:The mean itching scores were lower for eyes wearing the test lens as compared to those that received control lenses, indicating that the test lens effectively reduced allergic responses. Mean differences in itching were statistically and clinically significant (mean score difference ? 1) at both onset and duration for both trials. CONCLUSIONS:This large-scale assessment (n = 244) is the first demonstration of efficacy for CL delivery of a therapeutic for ocular allergy. Results are comparable to direct topical drug delivery and suggest that the lens/ketotifen combination can provide a means of simultaneous vision correction and treatment for CL wearers with ocular allergies.

SUBMITTER: Pall B

PROVIDER: S-EPMC6511424 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Management of Ocular Allergy Itch With an Antihistamine-Releasing Contact Lens.

Pall Brian B Gomes Paul P Yi Frank F Torkildsen Gail G

Cornea 20190601 6

<h4>Purpose</h4>A contact lens (CL)-based drug delivery system for therapeutic delivery of the antihistamine ketotifen was tested in 2 parallel, conjunctival allergen challenge-based trials.<h4>Methods</h4>Both trials employed the same multicenter, randomized, placebo-controlled protocol. Test lenses were etafilcon A with 0.019 mg ketotifen; control lenses were etafilcon A with no added drug. Subjects were randomized into 3 treatment groups. Group 1 received test lens in one eye and control lens ...[more]

PMID: 30908338

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Project description:PurposeContact lens-induced discomfort (CLD) remains a primary factor in discontinuation or prevention of contact lens wear. Thus, we investigated the role of ocular surface immune cells in subjects with CLD.MethodsHabitual contact lens (CL) wearers with CLD (n = 19; 38 eyes) and without CLD (n = 21; 42 eyes) as determined by the Contact Lens Dry Eye Questionnaire-8 was included in a trial. Enrolled subjects used either of the two types of CL (designated as CL-A or CL-D). Ocular surface cells from the bulbar conjunctiva were obtained by impression cytology. The collected cells were phenotyped using fluorochrome-conjugated antibodies specific for leukocytes (CD45+), neutrophils (CD66b+,High,Low), macrophages (CD163+), T cells (CD3+CD4+, CD3+CD8+), natural killer (NK) cells (CD56+, High, Low), natural killer T (NKT) cells (CD3+CD56+), and gamma delta T (γδT) cells (CD3+γδTCR+) by flow cytometry. Further, corneal dendritic cell density (cDCD) was also determined using in vivo confocal microscopy.ResultsSignificantly higher proportions of CD45+ cells were observed in subjects with CLD compared to those without CLD. The percentages of CD66bTotal,Low, CD163+, pan T cells, CD4+T cells, CD8+T cells, CD56Total,High,Low (NK) cells, and NKT cells, as well as the CD4/CD8 ratio, were significantly higher in CLD subjects. The proportion of T cells (CD4, CD8, CD4/CD8 ratio, NKT cells) and macrophages exhibited a direct association with discomfort score. The percentages of CD45+, CD66bTotal,Low, CD163+, CD3+, CD56Total,High,Low, and NKT cells and cDCD were significantly higher in CLD subjects wearing CL-D. The percentages of CD66bHigh, CD4+T cells, CD8+T cells, NKT cells, and CD4/CD8 ratio were significantly higher in CLD subjects wearing CL-A.ConclusionsIncreased proportions of ocular surface immune cells are observed in CLD, and the lens type could impact the immune cells associated with CLD.Translational relevanceThe association between the proportion of altered ocular surface immune cell subsets and contact lens-induced discomfort underpins the importance of considering immune-related aspects during contact lens development and in the clinical management of ocular surface pain.

Dataset Information

Management of Ocular Allergy Itch With an Antihistamine-Releasing Contact Lens.

Publications

Management of Ocular Allergy Itch With an Antihistamine-Releasing Contact Lens.

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