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NCT07395232 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Atopic Keratoconjunctivitis, sponsored by Dompé Farmaceutici S.p.A.

Recruiting
Registry status
Phase 3
Development phase
138
Enrollment target
19
Study locations

NCT07395232 is a Phase 3 study of Atopic Keratoconjunctivitis that is actively recruiting participants, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 138 participants. The trial reports 19 study locations across 8 states.

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The verdict

NCT07395232, a Phase 3 study of Atopic Keratoconjunctivitis, is actively recruiting participants, sponsored by Dompé Farmaceutici S.p.A.

RECRUITING
Registry status
Phase 3
Development phase
138 participants
Enrollment target
19
Study locations

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.

Interventions

  • DRUG Vehicle
  • DRUG DFL24498
  • DRUG dexamethasone sodium phosphate (DSP) ophthalmic solution

Study Locations (19)

Other

  • IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia - Bologna
  • Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti - Chieti
  • Azienda Ospedaliero Universitaria Careggi - Florence
  • Fondazione Policlinico Universitario Campus Bio-Medico - Roma
  • AOU Policlinico Umberto I - Roma
  • Azienda Ospedaliera Universitaria Integrata Verona - Verona
  • METAVISION ARRUZAFA S.L. (Hospital Arruzafa) - Córdoba
  • Miranza Galicia - Santiago de Compostela
  • Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM) - Valencia
  • OBA - Universidad de Valladolid - Valladolid
  • Hospital Universitario Miguel Servet - Zaragoza

Florida

  • Bowden Eye Associates - Southside Location - Jacksonville
  • University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute - Miami

Georgia

  • Clayton Eye Clinical Research - Morrow

Missouri

  • Ophthalmology Associates - St Louis

New York

  • NYU Langone Health - Eye Center - New York

North Carolina

  • Duke Eye Center - Ophthalmology - Durham

Tennessee

  • Total Eye Care, PA - Memphis

Texas

  • Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology - Houston

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2025-12-01
Est. Completion 2027-05
Phase Phase 3

Sponsor

Dompé Farmaceutici S.p.A

27 total trials

What the Registry Record Tells You About NCT07395232

The ClinicalTrials.gov registry entry for NCT07395232 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dompé Farmaceutici S.p.A, which has 27 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atopic Keratoconjunctivitis appearing as the primary indexed condition, and to 3 interventions - of which Vehicle is the first listed.

NCT07395232 reports 19 study locations spanning 8 distinct geographic areas - top geographies include Other, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT07395232 about?

NCT07395232 is a clinical study titled "An Efficacy and Safety Study of DFL24498 in the Treatment of AKC". 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 i...

What is the current status of trial NCT07395232?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 138 participants. The study started on 2025-12-01. Estimated completion is 2027-05.

What conditions does trial NCT07395232 study?

This clinical trial studies the following conditions: Atopic Keratoconjunctivitis.

What interventions are being tested in trial NCT07395232?

The interventions under investigation include: Vehicle (DRUG), DFL24498 (DRUG), dexamethasone sodium phosphate (DSP) ophthalmic solution (DRUG).

Who is sponsoring clinical trial NCT07395232?

This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07395232 being conducted?

This trial has 19 study locations across Florida, Georgia, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.