2023-508907-19-00已完成2 期
A 4-Week, Phase II, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study With 2 Weeks of Follow-Up to Evaluate Safety and Efficacy of Two Different Dosages of Isocyclosporin A Eye Drop Solution Versus Vehicle in Adult Patients with Atopic Keratoconjunctivitis (AKC).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 7
- 主要终点
- Mean change from baseline to Week 4 in ocular itching score assessed by visual analogue scale (VAS) [Time Frame: week 4].
研究概览
简要总结
To evaluate the efficacy of IsoCsA BID and QID versus vehicle to demonstrate superiority of at least one of the two different dosages over the vehicle in the improvement of ocular itching in adult patients with AKC.
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up period (weeks 5 and 6)
- 盲法
- Double (Subject, Monitor, Analyst, Carer, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥18 years.
- •Diagnosis of AKC in both eyes, with an ocular itching VAS score≥ 50 AND at least one of the following clinical characteristics in at least one eye: a. Presence of upper and/or lower tarsal conjunctival papillary reaction and/or limbal papillary reaction. b. A composite symptom score (CSyS) ≥4 (sum of the severity scores graded 0 to 3 for each of the following: itching, tearing, ocular discomfort, photophobia, and mucous discharge scored (composite symptom score range 0 to 15). c. Grade≥ 2 of superficial punctate keratitis as evaluated by corneal fluorescein staining modified Oxford scale (a seven-point ordinal scale [0, 0.5, 1, 2, 3, 4 and 5] with zero corresponding to complete clearing of the cornea). d. Bulbar conjunctival hyperemia score ≥ 1 on a 4-points scale (0-3)
- •Best corrected distance visual acuity score of +1.0 logMAR or better in both eyes at the time of study enrollment
- •If a female of childbearing potential, has a negative pregnancy test at both screening and baseline visit.
- •Only patients who satisfied all informed consent requirements will be included in the study; the patient and/or his/her legal representative must have read, signed, and dated the informed consent document before any study-related procedures were performed; the informed consent form signed by patients and/or legal representatives must have been approved by the IEC for the current study.
- •Has the ability and willingness to comply with study procedures.
- •For patients with concomitant dermatologic allergic manifestations, stable doses of topical calcineurin inhibitors (e.g., topical tacrolimus or topical pimecrolimus) for dermatological use, including periocular and eyelid skin, are allowed if on stable doses for 30 days prior to Baseline (Day 1) and anticipated to stay on pre-study stable doses for the entire study period. However, they are not allowed on the ocular surface.
- •Systemic immunomodulatory treatments for atopic dermatitis are allowed only if on stable doses for 30 days prior to Baseline (Day 1) and anticipated to stay on pre-study stable doses for the entire study period.
- •For patients with concomitant ocular conditions other than AKC that require topical ophthalmic medications, they may be included if the medications are not topical ophthalmic antiallergic, corticosteroids or calcineurin inhibitors and the patients have been on a stable dose for at least the past 3 months, which is anticipated to remain the same for the entire duration for the entire study period.
排除标准
- •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.
- •Females of childbearing potential (i.e., not surgically sterilized or postmenopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions: a. Are pregnant, b. Have a positive result at the urine pregnancy test (screening/baseline Day 1) c. Intend to become pregnant during the study treatment period, d. Are breastfeeding, e. Unwilling to continue to use highly effective birth control measures such as hormonal contraceptives (oral, implanted, transdermal, or injected), sexual abstinence (defined as refraining from heterosexual intercourse as usual and customary lifestyle) during the entire course of and 30 days after the study treatment period.
- •Male fertile patients (i.e. not surgically sterilized by vasectomy) unwilling to use an acceptable form of contraception (male condom with spermicidal cream or jelly).
- •Any concurrent medical condition that, in the judgment of the principal investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient’s well-being.
- •Use of topical ophthalmic cyclosporin A or other calcineurin inhibitors such as tacrolimus, pimecrolimus and topical ophthalmic corticosteroids in either eye in the past 2 weeks.
- •Contact lenses or punctum plug use during the study (previous use is not an exclusion criterion but must be discontinued at the Screening Visit/ Visit 1).
- •Diagnosis of other systemic diseases that are associated with ocular inflammation such as Sjogren’s disease, rheumatological diseases such as rheumatoid arthritis
- •History of drug addiction or alcohol abuse (>1 drink /day for women and >2 drinks /day for men following USDA dietary Guidelines 2020-2025).
- •Any prior ocular surgery (including cryosurgery or surgical excision of giant papillae) within 60 days before the screening visit in either eye.
- •Participation in a clinical trial with a new active substance, including medical devices in the past 60 days.
- •Participation in another clinical trial study at the same time as the present study
- •Evidence of an active ocular infection in either eye
- •Intraocular inflammation defined as Tyndall score >0 in either eye.
- •Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa)
- •Presence of cancer or any other systemic disease that may affect the ability to participate in the clinical study in the opinion of the investigator including basal cell carcinoma.
- •Patients that are anatomically monocular.
- •Systemic disease not stabilized within 1 month before the screening visit (e.g., diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (e.g., current systemic infections) or with a condition incompatible with the frequent assessment required by the study.
- •Received systemic administration of corticosteroids or immunosuppressive in the past 30 days prior to Screening visit.
- •History of a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds to the Study Product or a clinically significant allergy to drugs, foods, amide local anesthetics or other materials and drugs used in this study.
结局指标
主要结局
Mean change from baseline to Week 4 in ocular itching score assessed by visual analogue scale (VAS) [Time Frame: week 4].
Mean change from baseline to Week 4 in ocular itching score assessed by visual analogue scale (VAS) [Time Frame: week 4].
次要结局
- Mean change from baseline in ocular symptoms (itching, tearing, discomfort, mucous discharge, photophobia) composite score (0-15) [Time Frame: week 4, 6].
- Mean change from baseline in: - ocular itching evaluated on a 4-point scale(0-3)[Time Frame (TF): week 4, 6] - ocular tearing evaluated on a 4-point scale(0-3)[TF: week 4, 6] - ocular discomfort evaluated on a 4-point scale(0-3)[TF: week 4, 6] - ocular mucous discharge evaluated on a 4-point scale(0-3)[TF: week 4, 6] - photophobia evaluated on a 4-point scale(0-3)[TF: week 4, 6] - ocular itching score assessed by visual analog scale(VAS) [TF: week 2, 6]
- Mean change from baseline in ocular signs (Bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) composite score [Time Frame: week 4,6]. Mean change from baseline in blepharitis evaluated on a 4-point scale (0-3) [Time Frame: week 4, 6]
- Mean change from baseline of the Quality of Life (QoL) scores assessed by the Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ-S) Time Frame: week 4].
- Mean change from baseline in ocular symptoms and signs composite score (0-33) [Time Frame: week 4, 6].
- Mean change of post-instillation comfort score (0-4) [Time Frame: at baseline and week 2].
- Mean change from baseline in bulbar conjunctival hyperemia, evaluated on a 4-point scale (0-3) [Time Frame: week 2, 4, 6].
- Mean change from baseline in corneal epithelial fluorescein staining (modified Oxford scale) [Time Frame: week 2, 4, 6].
- Incidence and frequency of treatment-emergent adverse events (TEAEs) assessed throughout the study. Mean change from baseline in best corrected distance visual acuity (BCDVA) [Time Frame: at week 2, 4, 6]. Mean change from baseline in corneal endothelial cell density in both eyes (only at selected sites that have the required equipment) [Time Frame: at week 6] (for the other part please refer to protocol)
- Treatment discontinuation rate due to tolerability [Time Frame: at week 4]
- Descriptive pharmacokinetic (PK) assessment [Time Frame: baseline, at week 2, 4]
研究者
Marta Sacchetti, Global Head of Clinical Development Ophthalmology & Neurotrophins
Scientific
Dompe' Farmaceutici S.p.A.
研究点 (7)
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