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

Официальное название

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)

Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye. [Срок оценки: 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. [Срок оценки: Baseline and at Week 6]
• Change from baseline over time in ocular itching score assessed by VAS. [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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) [Срок оценки: Baseline and at Week 6 and Week 12.]
• Patient Global Impression of Change (PGIC) at week 6 and week 12. [Срок оценки: At week 6 and week 12.]
• Number of Participants receiving rescue medication over time after week 6 [Срок оценки: Week 6 to Week 12]
• Number of participants with treatment-emergent adverse events and serious adverse events (SAEs) [Срок оценки: Up to Week 16]
• Change from baseline over time in best corrected distance visual acuity (BCDVA) in each eye. [Срок оценки: Baseline and at Week 4, Week 6, Week 8, Week 12, and Week 16]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 8 центров

• 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

Италия · 6 центров

• 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

Испания · 5 центров

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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