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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

9 May 2025 → ongoing

Decision date (initial)

2023-12-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

Our objective is to assess the efficacy of Ikervis administered 4 times daily for 4 months as treatment for atopic keratokonjunctivitis.

Conditions and MedDRA coding

Atopic Keratoconjunctivitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. At least 18 years of age
2. 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
3. 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)
4. Ability to undergo and return for study-related scheduled appointments

Exclusion criteria 18

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline to 4 months follow-up in the Bulbar Redness (BR) score measured on the Keratograph 5M (K5M, Oculus®) with an R-scan, Automatic Classification of Redness.

Secondary endpoints 9

1. Ocular discomfort as described by patients on 100 mm VAS
2. Ocular Surface Disease Index (OSDI) score
3. Ocular surface staining (Oxford score)
4. Tear osmolarity (TearLab®)
5. Tear meniscus height (TMH, K5M)
6. Non-invasive tear break-up time (NIKBUT, K5M)
7. Meibography (JENVIS Meibo Grading Scale, K5M)
8. Schirmer’s I test
9. Fluorescein tear break-up time (TBUT)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Nordre Ringvej 57

City

Glostrup

Postcode

2600

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Steffen Heegaard

Public contact point

Organisation

Rigshospitalet

Contact name

Steffen Heegaard

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications