A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Adult Participants with Atopic Keratoconjunctivitis (AKC)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522291-83-00

Acronym

ICY-AKC-301

Enrollment

104

Registered

2025-11-12

Start date

2025-11-27

Completion date

Unknown

Last updated

2025-11-17

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 at week 6 in ocular itching score assessed by visual analog scale (VAS).

Detailed description

Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye, Change from baseline at week 6 in bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100), in the study eye.

Interventions

DRUGPlacebo (Vehicle) for investigational DFL24498

DRUGIsocyclosporin A

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).	—

Secondary

Measure	Time frame
Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye, Change from baseline at week 6 in bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100), in the study eye.	—

Countries

Italy, Spain

Outcome results

None listed

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