NCT07395232招募中3 期
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)
Dompé Farmaceutici S.p.A19 个研究点 分布在 3 个国家目标入组 138 人开始时间: 2025年12月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 19
- 主要终点
- Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).
研究概览
简要总结
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.
详细描述
The study will consist of 3 periods:
- Screening period (from Day -7 ± 1 to Day 1),
- Treatment Period (from randomization through Week12) and
- Follow-up period (Weeks 13 to 16).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
DFL24498
Experimental
Participants will be administered with DFL24498 eye drops in both eyes.
干预措施: DFL24498 (Drug)
DFL24498
Experimental
Participants will be administered with DFL24498 eye drops in both eyes.
干预措施: dexamethasone sodium phosphate (DSP) ophthalmic solution (Drug)
Vehicle
Placebo Comparator
Participants will be administered with vehicle eye drops in both eyes.
干预措施: Vehicle (Drug)
Vehicle
Placebo Comparator
Participants will be administered with vehicle eye drops in both eyes.
干预措施: dexamethasone sodium phosphate (DSP) ophthalmic solution (Drug)
结局指标
主要结局
Change from baseline at week 6 in ocular itching score assessed by visual analog scale (VAS).
时间窗: 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.
次要结局
- Change from baseline at week 6 in corneal epithelial fluorescein staining, scored by modified Oxford scale, in the study eye.(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.(Baseline and at Week 6)
- Change from baseline over time in ocular itching score assessed by VAS.(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).(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.(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.(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.(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)(Baseline and at Week 6 and Week 12.)
- Patient Global Impression of Change (PGIC) at week 6 and week 12.(At week 6 and week 12.)
- Number of Participants receiving rescue medication over time after week 6(Week 6 to Week 12)
- Number of participants with treatment-emergent adverse events and serious adverse events (SAEs)(Up to Week 16)
- Change from baseline over time in best corrected distance visual acuity (BCDVA) in each eye.(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).(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).(Baseline and at week 12)
- Change from baseline over time in intraocular pressure in each eye.(Baseline and at Week 6 and Week 12)
- Number of participants discontinued due to tolerability during the treatment period(Baseline to week 12)
研究者
研究点 (19)
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