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

Official title

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)

Overview

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).

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.

Primary outcome measures

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

Secondary outcome measures (12)

• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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 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.]
• Patient Global Impression of Change (PGIC) at week 6 and week 12. [Time frame: At week 6 and week 12.]
• Number of Participants receiving rescue medication over time after week 6 [Time frame: Week 6 to Week 12]
• Number of participants with treatment-emergent adverse events and serious adverse events (SAEs) [Time frame: 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]

Eligibility criteria

Inclusion criteria

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

• Men or women aged ≥ 18 and ≤ 65 years of age.
• Diagnosis of AKC in both eyes, including the presence or medical history of the following:

• other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND
• chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis.
• Ocular itching of at least 50 as assessed by VAS scale.
• 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.
• 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).
• 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:

• 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.
• Evidence of an active ocular infection in either eye.
• Intraocular inflammation defined as anterior chamber flare > 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
• Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa).
• 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.
• Participants that are anatomically monocular.
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 8 centers

• Bowden Eye Associates - Southside Location — Jacksonville
• University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute — Miami
• Clayton Eye Clinical Research — Morrow
• Ophthalmology Associates — St Louis
• NYU Langone Health - Eye Center — New York
• Duke Eye Center - Ophthalmology — Durham
• Total Eye Care, PA — Memphis
• Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology — Houston

Italy · 6 centers

• 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

Spain · 5 centers

• 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

Identifiers

NCT: NCT07395232 · ICY-AKC-301 · 2025-522291-83-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗