NCT07395232

An Efficacy and Safety Study of DFL24498 in the Treatment of AKC

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. Approximately 138 participants who meet all eligibility criteria will be enrolled in the study.

Detailed description

The study will consist of 3 periods: 1. Screening period (from Day -7 ± 1 to Day 1), 2. Treatment Period (from randomization through Week12) and 3. Follow-up period (Weeks 13 to 16).

Conditions

• Atopic Keratoconjunctivitis

Interventions

Type	Name	Description
DRUG	DFL24498	DFL24498 will be instilled in each eye for 12 Weeks.
DRUG	Vehicle	Vehicle eye drops without active drug will be instilled in each eye for 12 Weeks.
DRUG	dexamethasone sodium phosphate (DSP) ophthalmic solution	Rescue medication may be administered as required at the Investigator discretion.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-03-01
• Completion: 2027-05-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

19 sites across 3 countries: United States, Italy, Spain

Regulatory

• FDA-regulated drug study