Ikervis in the Treatment of Atopic Keratoconjunctivitis - a Prospective, Randomized, Placebo-Controlled Trial

Rigshospitalet0 个研究点目标入组 40 人开始时间: 2023年9月19日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•At least 18 years of age, Atopic dermatitis graded as at least mild: a.EASI-score of at least 1.1 at last dermatologist visit no more than 6 months prior to screening visit, or b.POEM-score of 3 if no dermatologist visits 6 months prior to screening visit, Atopic keratoconjunctivitis with all the following at the time of inclusion: a. At least mild posterior blepharitis/meibomian gland dysfunction (by evaluation of the central ten meibomian gland openings of the upper eyelids with at least 1 gland plugged); b. Signs of conjunctivitis as evaluated via the Bulbar Redness score (r-scan K5M) =2; c. Corneal fluorescein staining (CFS) = 1-4 (oxford grading scheme), Ability to undergo and return for study-related scheduled appointments

•Individuals who by the physician/clinical staff are evaluated not to be able to corporate to examination, History of systemic malignancy within 3 years before the study, History of drug addiction or alcoholic abuse within the past 2 years, History or presence of systemic disorder, disease or condition, that possibly could interfere with study results, Wear of contact lenses during the study, Pregnancy or breastfeeding at study entry, Change in systemic anti-inflammatory treatment 30 days before the study or anticipated change during the study, Use of topical corticosteroid in the eye or periocular 30 days before the study, Use of systemic calcineurin inhibitors or topical calcineurin inhibitors in the eye or periocular within 90 days before the study, Known allergy or sensitivity to the study medications or their components, Inability to complete prescribed treatment, Active or suspected ocular or periocular infections, Active or history of ocular herpes, Any current ocular treatment except lubricant eyedrops, mast-cell stabilizers or antihistamines, Abnormal blinking function or lid anatomy, Refractive surgery within two years before the study or during the study, Ocular or periocular malignant or premalignant conditions, History or presence of ocular disorder, disease, condition or trauma, that possibly could interfere with study results

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