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

Conditions

• Atopic Keratoconjunctivitis

Eligibility Criteria

Sex

ALL

Age

10 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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. The study consists of 2 cohorts: the adult cohort includes approximately 138 participants and the pediatric cohort which includes approximately 15 participants. The cohorts will be randomized separately. Adult participants will be randomized in a 1:1 ratio, while pediatric participants will be randomized in a 2:1 ratio to receive DFL24498 or vehicle.

Key Dates

First listed

Feb 9, 2026

Start date

Dec 1, 2025

Status verified

Sep 2026

Primary completion

Mar 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

153 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: DFL24498
  Participants will be administered with DFL24498 eye drops in both eyes.
• Placebo Comparator: Vehicle
  Participants will be administered with vehicle eye drops in both eyes.

Primary Outcome Measure

Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS). [ Time Frame: Baseline and at Week 6 ]

Central Contacts

• Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
  +39 02 583 831

Locations (8)

Find similar trials in Jacksonville, FL