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

NCT07395232 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Atopic Keratoconjunctivitis

Interventions

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.

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-03-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07395232 on ClinicalTrials.gov