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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500633-92-00

Enrollment

Registered

2023-12-13

Start date

2025-05-09

Completion date

Unknown

Last updated

2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Keratoconjunctivitis

Brief summary

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.

Detailed description

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

Interventions

DRUGCationorm PRO is a autorized medical device that contains no pharmeceutical ingredient.

DRUGIKERVIS 1 mg/mL eye drops

DRUGemulsion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Ocular discomfort as described by patients on 100 mm VAS, Ocular Surface Disease Index (OSDI) score, Ocular surface staining (Oxford score), Tear osmolarity (TearLab®), Tear meniscus height (TMH, K5M), Non-invasive tear break-up time (NIKBUT, K5M), Meibography (JENVIS Meibo Grading Scale, K5M), Schirmer’s I test, Fluorescein tear break-up time (TBUT)	—

Primary

Measure	Time frame
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.	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026