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

April 16, 2026 updated by: Dompé Farmaceutici S.p.A

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
  • Phone Number: +39 02 583 831

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia
      • Chieti, Italy, 66100
        • Recruiting
        • Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti
      • Florence, Italy, 50134
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi
      • Roma, Italy, 00161
        • Recruiting
        • AOU Policlinico Umberto I
      • Roma, Italy, 00128
        • Recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico
      • Verona, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
  • Spain
      • Córdoba, Spain, 14012
        • Recruiting
        • METAVISION ARRUZAFA S.L. (Hospital Arruzafa)
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Miranza Galicia
      • Valencia, Spain, 46015
        • Recruiting
        • Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM)
      • Valladolid, Spain, 47011
        • Recruiting
        • OBA - Universidad de Valladolid
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Bowden Eye Associates - Southside Location
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Recruiting
        • Clayton Eye Clinical Research
    • Missouri
      • St Louis, Missouri, United States, 63131
        • Recruiting
        • Ophthalmology Associates
    • New York
      • New York, New York, United States, 10017
        • Recruiting
        • NYU Langone Health - Eye Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Eye Center - Ophthalmology
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Total Eye Care, PA
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Men or women aged ≥ 18 and ≤ 65 years of age.

  2. Diagnosis of AKC in both eyes, including the presence or medical history of the following:

    1. other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND
    2. chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis.
  3. Ocular itching of at least 50 as assessed by VAS scale.
  4. Corneal fluorescein staining assessed by modified Oxford scale of at least grade 1 AND a bulbar conjunctival hyperemia assessed by VBR 10 scale of at least 40 (range 0 to 100) in the same eye.
  5. A composite symptoms score (CSyS) ≥ 5 (sum of the severity scores graded 0 to 3 for each of the following: itching, tearing, ocular discomfort, photophobia, and mucous discharge score) (CSyS range of 0 to 15).
  6. If a woman of childbearing potential (WOCBP), must have a negative pregnancy test at both screening and baseline visit, and use an acceptable contraception method.

Exclusion Criteria:

Participants will be excluded if any of the following criteria apply:

  1. Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.
  2. Evidence of an active ocular infection in either eye.
  3. Intraocular inflammation defined as anterior chamber flare > 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
  4. Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa).
  5. Presence of cancer or any other systemic or unstable disease that may affect the ability to participate in the clinical study in the opinion of the investigator including basal cell carcinoma.
  6. Participants that are anatomically monocular.
  7. Systemic disease not stabilized within 1 month before the screening visit (eg, diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (eg, current systemic infections) or with a condition incompatible with the frequent assessment required by the study.

Note: Additional protocol defined Inclusion/Exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DFL24498
Participants will be administered with DFL24498 eye drops in both eyes.
Drug: DFL24498
DFL24498 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.
Placebo Comparator: Vehicle
Participants will be administered with vehicle eye drops in both eyes.
Drug: dexamethasone sodium phosphate (DSP) ophthalmic solution
Rescue medication may be administered as required at the Investigator discretion.
Drug: Vehicle
Vehicle eye drops without active drug will be instilled in each eye for 12 Weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).
Time Frame: Baseline and at Week 6
The ocular itching VAS ranges from 0 to 100 mm (0 mm = no ocular itching at all, 100 mm = intolerable itching). Participants will be asked to subjectively rate the current severity of ocular itching at each time point.
Baseline and at Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye.
Time Frame: Baseline and at Week 6
Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. Examination will be performed at the slit-lamp using blue (cobalt) light. Corneal fluorescein staining will be graded according to the modified Oxford scale (7-point scale: 0, 0.5. 1, 2, 3, 4, 5).
Baseline and at Week 6
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.
Time Frame: Baseline and at Week 6
Bulbar conjunctival redness will be assessed at the slit-lamp examination using white light prior to vital dye instillation and graded according to the VBR 10 scale.
Baseline and at Week 6
Change from baseline over time in ocular itching score assessed by VAS.
Time Frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
The ocular itching VAS ranges from 0 to 100 mm (0 mm = no ocular itching at all, 100 mm = intolerable itching). Participants will be asked to subjectively rate the current severity of ocular itching at each time point.
Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in ocular symptoms of itching, tearing, discomfort, mucous discharge, and photophobia on a 4-point scale (0 to 3).
Time Frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Ocular symptoms are assessed using a 4-point severity scale ranging from 0 (none) to 3 (severe). Five ocular symptoms, itching, tearing, ocular discomfort (including burning, stinging, and foreign body sensation), mucous discharge, and photophobia are evaluated in the study eye. A composite symptom score is described in calculated at screening and Baseline by summing the individual symptom scores, resulting in a total score range of 0 to 15, with higher scores indicating greater symptom severity.
Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in corneal fluorescein staining (modified Oxford scale) in the study eye.
Time Frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Corneal fluorescein staining modified Oxford scale (0-5) as per corneal dot count in each eye.
Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in bulbar conjunctival hyperemia assessed by VBR 10 scale (0 to 100) in the study eye.
Time Frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Bulbar conjunctival hyperemia assessed by Validated Bulbar Redness (VBR) 10 scale (0 to 100).
Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline over time in signs of tarsal papillary reaction, corneal neovascularization, cicatrizing conjunctivitis and blepharitis on a 4-point scale (0 to 3) in the study eye.
Time Frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change in signs on a 4-point scale (0 to 3) in the study eye.
Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline at week 6 and 12 in the QoL scores assessed by the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ-S)
Time Frame: Baseline and at Week 6 and Week 12.
Standardized Rhinoconjunctivitis QoL Questionnaire (RQLQ[S]) is a validated questionnaire that assesses QoL specifically in patients with rhinoconjunctivitis. There are 28 questions, which are categorized under 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Each question is scored on a 7-point scale from no impairment (score 0) to severe impairment (score 6).
Baseline and at Week 6 and Week 12.
Patient Global Impression of Change (PGIC) at week 6 and week 12.
Time Frame: At week 6 and week 12.
PGIC is a short questionnaire used to assess how a participant perceives changes in their condition following treatment, on a scale ranging from 1 to 7.
At week 6 and week 12.
Number of Participants receiving rescue medication over time after week 6
Time Frame: Week 6 to Week 12
Participants who received rescued medication over time after week 6 (visit 4).
Week 6 to Week 12
Number of participants with treatment-emergent adverse events and serious adverse events (SAEs)
Time Frame: Up to Week 16
Any adverse events occurring or worsening after the first administration of investigational product is classified as "treatment-emergent" adverse events and does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.
Up to Week 16
Change from baseline over time in best corrected distance visual acuity (BCDVA) in each eye.
Time Frame: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Best corrected visual acuity (BCDVA) is determined by careful refraction according to the standard protocol for refraction. BCDVA is measured by Early Treatment of Diabetic Retinopathy Study chart.
Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline at week 12 in corneal endothelial cell density in each eye (only at selected sites that have the required equipment).
Time Frame: Baseline and at week 12
Corneal central region endothelial cell density will be determined for each eye using specular microscopy and expressed as the number of cells/mm2 using the Cell Density readout provided by the software.
Baseline and at week 12
Change from baseline at week 12 in dilated fundus exam in each eye (proportion of participants with vitritis, retinal or vitreal hemorrhages, increase in cup-to-disc ratio, retinal or posterior vitreal detachment, retinal tears, or maculopathy).
Time Frame: Baseline and at week 12
After specular microscopy, mydriatic drops will be instilled in both eyes and once adequate dilation is achieved, a fundal exam shall be performed to examine the vitreous, retina, and optic nerve.
Baseline and at week 12
Change from baseline over time in intraocular pressure in each eye.
Time Frame: Baseline and at Week 6 and Week 12
IOP will be assessed by applanation tonometry for each eye and will be measured in mmHg.
Baseline and at Week 6 and Week 12
Number of participants discontinued due to tolerability during the treatment period
Time Frame: Baseline to week 12
Treatment discontinuation rate due to tolerability.
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dompé Farmaceutici S.p.A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICY-AKC-301
  • 2025-522291-83-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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