2024-513489-20-00招募中3 期
A Phase 3, multicenter, randomized, evaluator-blinded clinical trial to assess the safety and efficacy of Clobetasol propionate ophthalmic nanoemulsion, 0.05% compared to Prednisolone acetate, 1% in the treatment of inflammation after cataract surgery in pediatric population 0 to 3 years of age (CLOSE-3).
Laboratorios Salvat S.A., Laboratorios Salvat S.A.8 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Number, frequency, severity and relationship to IMP of adverse events (AEs) up to last study visit
研究概览
简要总结
To assess the safety of Clobetasol propionate ophthalmic nanoemulsion, 0.05% treatment after cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the day of consent.
- •Patients who are candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
- •Patients whose caregiver(s) is/are able and willing to comply with all treatment and follow-up procedures
- •Signed informed consent from (ICF) parents or patient's legally authorized representative(s).
- •Patients who have undergone routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
- •Patients with clinical evidence of postoperative inflammation (anterior chamber inflammation grade > 0).
排除标准
- •Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
- •History of steroid-induced increase in IOP in either eye
- •Patients with glaucoma, ocular hypertension, or those receiving IOP lowering therapy in either eye or systemically
- •Any current corneal abrasion or ulceration
- •Known or suspected allergy or hypersensitivity to similar drugs, such as other corticosteroids, or their components
- •Patients who have had ocular surgery in the study eye within 90 days prior to surgery
- •History of post-operative unresolved inflammation in the contralateral eye
- •Presence or history of chronic generalized systemic disease that the Investigator believes may either increase the risk to the subject or confound the results of the study (e.g., Diabetes mellitus, human immunodeficiency virus [HIV], acquired immunodeficiency syndrome [AIDS]).
- •Any concurrent process which, in the opinion of the investigator, could impair patients' safety or limit adherence to the study protocol
- •Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study
- •Prior participation in the study described in this protocol unless the patient wasn't randomized
- •Active uveitis in the study eye
- •Ocular neoplasia in the study eye
- •Post-traumatic cataract in the study eye
- •Suspected permanent low vision or blindness in the fellow non-study eye. The study eye must not be the patient's only good eye
- •Use of any topical medication in the study eye within 2 days prior to surgery, except for those required for ocular examination or preoperative preparation
- •Systemic administration of any steroidal anti inflammatory drugs in the previous 2 weeks prior to the surgery, except for those required for preoperative preparation.
- •Systemic administration of any non-steroidal anti inflammatory drugs in the previous 48 hours prior to the surgery, except for those required for preoperative preparation
- •Patient or patient's breastfeeding mother who is expected to use corticosteroids (except corticosteroid inhalers and dermatological corticosteroids, as long as they are not used on the eyelids or surrounding area, and oral prednisolone steaglate drops as part of the standard treatment after cataract surgery) or immunosuppressants during the 30 days following cataract surgery
结局指标
主要结局
Number, frequency, severity and relationship to IMP of adverse events (AEs) up to last study visit
Number, frequency, severity and relationship to IMP of adverse events (AEs) up to last study visit
Number, frequency, severity and relationship to IMP of Serious AE (SAEs) up to last study visit
Number, frequency, severity and relationship to IMP of Serious AE (SAEs) up to last study visit
Proportion of patients discontinuing the study due to AEs
Proportion of patients discontinuing the study due to AEs
Proportion of patients discontinuing the study due to lack of efficacy
Proportion of patients discontinuing the study due to lack of efficacy
Change from baseline to each study visit in intraocular pressure (IOP)
Change from baseline to each study visit in intraocular pressure (IOP)
Change from baseline to each study visit in visual acuity and physical and eye examination parameters
Change from baseline to each study visit in visual acuity and physical and eye examination parameters
次要结局
- Percentage of patients with anterior chamber inflammation of grade 0 at Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3).
- Change from baseline to Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3) in the proportion of patients with different grades of anterior chamber inflammation
- Proportion of patients with Grade 1, Grade 2, Grade 3 and Grade 4 of anterior chamber inflammation at Visit 1 (Day 1), Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3).
- Frequency of different signs and symptoms of ocular inflammation at baseline, Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3).
- Change from baseline to Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3) in the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale Score
研究者
Enrique Jiménez
Scientific
Laboratorios Salvat S.A.
研究点 (8)
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