NCT04485533Unknown不适用
Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Ophthalmic Gel Administered in Patients Affected by Moderate Dry Eye Disease (DED): a Randomized, Cross Over, Double Blind Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Tear Break-Up Time (TBUT)
研究概览
简要总结
This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).
详细描述
The purpose of the study is to evaluate the non-inferiority of the new treatment versus the comparator.
Patients, after signing the Informed Consent, will enter into a 1-week screening phase during which the baseline tests will be conducted.
Baseline (V0), Day 30 ± 1 week (V1), Day 38 ± 2 days (V2), Day 68 ±1 week (V3) of treatment.
Between V1 and V2 one week of wash out should be performed. Of note, all ophthalmologic evaluations listed in the Flow-Chart will be performed on both eyes of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Informed consent form (ICF) signed.
- •Males and Females aged ≥18 years at the time of the signature of ICF.
- •Patients with moderate dry eye disease (DED) according to IDEEL questionnaire (score ≥51 and ≤64) and diagnosed at least 3 months before enrolment.
- •No use of other tear substitutes in the 5 days prior to enrolment, except for refresh solutions.
- •TBUT value <6 sec.
- •Willing to follow all study procedures, including attending all site visits, tests and examinations.
- •Women must agree to be using two forms of effective contraception, be post-menopausal from at least 12 months prior to trial entry, or surgically sterile.
排除标准
- •Patients with a mild or severe dry eye disease (DED) according to IDEEL questionnaire (score ≤50 and ≥65, respectively).
- •Use of ophthalmologic products in the 14 days prior to enrolment, except for refresh solutions and stable glaucoma treatment.
- •No previous history or presence of any disease involving cornea or conjunctiva.
- •Sjӧgren syndrome.
- •History or active cicatricial conjunctivitis.
- •History of ocular surface burns.
- •Use of contact lenses.
- •Corneal refractive surgery 1 year post-operative.
- •Any ocular surgery in the previous 3 months preceding the study.
- •Unstable glaucoma (treatment changes in the last year).
- •Any macular or retinal disease that could impact visual acuity.
- •Best corrected visual acuity (BCVA) below 20/
- •Blepharitis treatment started less than 3 months before enrolment.
- •Neurological, neurodegenerative or cerebrovascular conditions.
- •Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular, cancer or hematological disease.
- •Unstable treatment with systemic medications, such as diuretics, antihistamines, antidepressants, psychotropics, cholesterol lowering agents and beta-blockers.
- •Known hypersensitivity to one of the administered products.
- •Known drug and/or alcohol abuse.
- •Mental incapacity that precludes adequate understanding or cooperation.
- •Participation in another investigational study or blood donation within 1 month prior to ICF signature.
结局指标
主要结局
Tear Break-Up Time (TBUT)
时间窗: through study completion, an average of 2.5 months
To evaluate the effect of treatment with VisuXL® GEL versus HYLO® on the stability of the tear film by Tear Break-Up Time (TBUT) in patients affected by moderate dry eye disease (DED).
次要结局
- Functional Visual Acuity (FVA)(through study completion, an average of 2.5 months)
- Tear secretion(through study completion, an average of 2.5 months)
- Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)(through study completion, an average of 2.5 months)
- Burning, foreign body sensation, itching, and photophobia symptoms of DED assessed by Visual Analogue Scale (10 points VAS)(through study completion, an average of 2.5 months)
- Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale(through study completion, an average of 2.5 months)
- Corneal inflammation assessed by staining grade with SICCA Scale(through study completion, an average of 2.5 months)
- Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL(through study completion, an average of 2.5 months)
- Each of the three modules that are part of IDEEL questionnaire(through study completion, an average of 2.5 months)
- Number of participants with treatment-related Adverse Events and Adverse Device Events assessed in a descriptive way(through study completion, an average of 2.5 months)
研究者
研究点 (6)
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