CTIS2022-500633-92-00Active, not recruitingPhase 1
Ikervis in the Treatment of Atopic Keratoconjunctivitis - a Prospective, Randomized, Placebo-Controlled Trial
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Rigshospitalet
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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