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Ikervis in the Treatment of Atopic Keratoconjunctivitis - a Prospective, Randomized, Placebo-Controlled Trial
EU CTIS ID: 2022-500633-92-00
What this study is testing
Our objective is to assess the efficacy of Ikervis administered 4 times daily for 4 months as treatment for atopic keratokonjunctivitis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.