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0.30%和0.15%透明质酸滴眼液的性能和安全性评价

2026年9月15日 更新者：Fidia Farmaceutici s.p.a.

含 0.30% 透明质酸钠盐和氨基酸（不含 BLUyal A）的滴眼液对中重度干眼症患者和含 0.15% 透明质酸钠盐和氨基酸（不含 BLUyal A）的眼药水的疗效和安全性评价患有轻度干眼症

This is a profit, multicentric, prospective, open-label, non-pharmacological clinical investigation aim to evaluate the efficacy and tollerability of two types of eye drops containing Hyaluronic acid (HA) with different concentration as 0.30% (BLUgel A) and 0.15% (BLUyal A). the study will consider patients affected by moderate to severe dry eye syndrome which will be treated with HA 0.30% while patients affected by mild dry eye syndrome will be treated with HA 0.15%.Dry eye syndrome (DES) is defined as a multifactorial disease of the ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface.Based on the available background on the use of HA in the management of DES, this investigation has been designed to assess the efficacy of HA- and amino acid-based product BLUgel A free and BLUyal A free, in patients with moderate to severe and mild dry eye syndrome, respectively.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a profit, multicentric, prospective, open-label, non-pharmacological clinical investigation. Patients will have an initial screening/baseline Visit 1-T0 (day 0). Patients with diagnosis of moderate to severe dry eye syndrome will start a 60 days treatment period with BLUgel A free (2 drops per eye, 3 times a day, bilaterally), while patients with diagnosis of mild dry eye syndrome will start a 60 days treatment period with BLUyal A free (2 drops per eye, 3 times a day, bilaterally).

The following on-site visits will be performed: Visit 2-T1 (day 15 [+3]), Visit 3-T2 (day 30 [+3]) and Visit 4-T3 (day 60 [+3]). Visit 3-T2 and Visit 4-T3 should be performed preferably at day 30 and day 60 respectively. In case Visit 3-T2 is postponed within the allowed window, treatment has to be continued by the patient without interruption.

A total of 100 male or female patients who have been diagnosed with mild or moderate to severe dry eye syndrome are planned to be enrolled. Dry eye syndrome will be classified according to Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS) (2007 version) definition. Patients with diagnosis of moderate to severe dry eye syndrome will be treated with BLUgel A free for 60 days, patients with diagnosis of mild dry eye syndrome will be treated BLUyal A free for 60 days. Patients will be stratified in the two categories of severity, i.e. 50 patients with moderate/severe dry eye syndrome treated with BLUgel A free and 50 patients with mild dry eye syndrome treated with BLUyal A free.

Patients are not permitted to use a concomitant drug or device interfering with the dryness of the eye, such as corticosteroid and antibiotic eye drops; instead, they are permitted to use any drug or device non-interfering with the treatment of dry eye syndrome and not affecting the effectiveness of BLUgel A free or BLUyal A free or the occurrence of adverse reactions.

研究类型

介入性

注册 (实际的)

101

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 意大利
    • CZ
      • Catanzaro、CZ、意大利、88100
        • Azienda Ospedaliera Universitaria-Renato Dulbecco
    • Firenze
      • Florence、Firenze、意大利、50134
        • AOU Careggi
    • Milano
      • Milan、Milano、意大利、20142
        • ASST Santi Paolo e Carlo P.O San Paolo

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Patients who meet all the following criteria at the screening/baseline visit will be considered as eligible for the investigation:

  1. Patients having signed written informed consent to participate in the investigation obtained according to Good Clinical Practice (GCP);

  2. Patients having an age ≥ 18 years;

  3. Patients with diagnosis of dry eye syndrome (according to Tear Film and Ocular Surface Society [TFOS] Dry Eye Workshop [DEWS] definition);

  4. Diagnosis of dry eye syndrome for the investigation assessed through at least the following exams: slit lamp examination (SLE), tear (lacrimal) meniscus exam, Schirmer's test I, TFBUT, cornea and conjunctiva staining, IDEEL questionnaire ("Dry Eye Symptom-Bother" module); 4a) Diagnosis of mild dry eye syndrome will be based on the following criteria:

    • TFBUT 7-10 sec
    • Schirmer's test I 7-10 mm
    • Fluorescein staining of the cornea and conjunctiva (NEI scale value) <7
    • IDEEL questionnaire ("Dry Eye Symptom-Bother" module) score 40-50
    • Patient not treated in the previous 15 days for dry eye syndrome 4b) Diagnosis of moderate to severe dry eye syndrome will be based on the following criteria:
    • TFBUT < 7 sec
    • Schirmer's test I < 7 mm
    • Fluorescein staining of the cornea and conjunctiva (NEI scale value) ≥7
    • IDEEL questionnaire ("Dry Eye Symptom-Bother" module) score >50
    • Dry eye syndrome treatment permitted; no ophthalmic gel treatment permitted

    In case of bilateral dry eye syndrome, both eyes will be treated but only the worst eye, defined as the eye with the higher severity of impairment according to the Investigator's judgment based on the above exams, will be considered for assessments (although both eyes will be treated). In the case of bilateral dry eye syndrome with both eyes having the same level of impairment, the right eye will be considered for assessments by convention; In case of monolateral dry eye syndrome, both eyes will be treated. Evaluations of both the eyes will be collected but only target eye evaluations will be used for statistical analysis.

  5. Patients being able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and patients able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on Investigator's judgment;

  6. Female patients having a negative urine pregnancy test result at screening and using an appropriate method of contraception for at least 30 days before inclusion and during the whole investigation period, according to the definition of Note 3 of ICH M3 Guideline*, if females of childbearing potential (i.e., not permanently sterilized - post hysterectomy or tubal ligation status - or not postmenopausal);

    • Note: According to the definition of Note 3 of ICH M3 Guideline a highly effective method is defined as those which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Highly effective birth control methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.

Exclusion Criteria:

Patients who fulfil any of the following criteria at the screening/baseline visit will be excluded from the investigation:

  1. Patients with mild dry eye syndrome that have used eye drops product in the 15 days preceding the screening/baseline visit.

    Patients with moderate to severe dry eye syndrome may have used treatment for dry eye syndrome in the 15 days preceding the screening/baseline visit, with the exception of gel compounds;

  2. Patients under treatment with corticosteroids or antibiotics eye drops, hypotony-inducing products or any other therapy that, as per Investigator's opinion, could interfere with the assessment of the efficacy or incidence of adverse events;

  3. Patients with presence or history of any systemic or ocular disorder, condition or disease (with particular attention to malignancies and neuro-oncological diseases) that, according to Investigator's judgment, can interfere with the conduct of the required investigation procedures or the assessment of the efficacy or the interpretation of the investigation results or the incidence of adverse events;

  4. Patients with glaucoma;

  5. Patients that use therapeutic or refractive contact lenses;

  6. Patients with hypersensitivity and/or allergy to any of the BLUgel A free or BLUyal A free ingredients;

  7. History of ocular surgery in either eye, excluding corneal refractive or cataract procedures, within 90 days of investigation enrolment;

  8. Patients not being able to apply during the investigation any eye drops product;

  9. Patients treated with antidepressant, antiepileptic, antihistamine, anticholinergic drug;

  10. Patients participating to another clinical study/investigation at the same time as the present investigation or within 30 days;

  11. Patients who have history of drug, medication or alcohol abuse or addiction

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Group A

Patients with diagnosis of moderate to severe dry eye syndrome will start a 60 days treatment period with BLUgel A free (2 drops per eye, 3 times a day, bilaterally)
设备：BLUgel A

BLUgel A: Hyaluronic Acid Eye Drops 0.30%
实验性的：Group B

Patients with diagnosis of mild dry eye syndrome will start a 60 days treatment period with BLUyal A free (2 drops per eye, 3 times a day, bilaterally).
设备：BLUyal A

BLUyal A:Hyaluronic Acid Eye Drops 0.15%

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Efficacy Assessment from baseline
大体时间：Day 30

-Changes from baseline (T0) to Day 30 (T2) of overall score of National Eye Institute (NEI) corneal (range 0-15) and conjunctival (range 0-18) fluorescein staining, following treatment with BLUgel A free ophthalmic solution in patients with moderate to severe dry eye syndrome;
Day 30
Changes in Tear Film Break-Up Time (TFBUT) from baseline
大体时间：Day 30

- Changes from baseline (T0) to Day 30 (T2) in Tear Film Break-Up Time (TFBUT) values, following treatment with BLUyal A free ophthalmic solution in patients with mild dry eye syndrome. The TFBUT will be measured twice during the first minute after the instillation of the fluorescein. If the 2 readings differ by more than 2 seconds a third reading will be taken. The TFBUT value will be the average of the 2 or 3 measurements.
Day 30

次要结果测量

结果测量
措施说明
大体时间
Efficacy Assessment from baseline in patients with moderate to severe dry eye syndrome
大体时间：Day 60

Change from baseline (T0) to Day 60 (T3) of overall score of NEI corneal (range 0-15) and conjunctival fluorescein (range 0-18) staining following treatment with BLUgel A free, and change from baseline (T0) to Day 30 (T2) and Day 60 (T3) of overall score of NEI corneal and conjunctival fluorescein staining following treatment with BLUyal A free ophthalmic solution. the maximum score of the sum of NEI corneal and conjunctival total score is 33.
Day 60
Efficacy Assessment from baseline
大体时间：Day 30 and Day 60
  • Changes from baseline (T0) to Day 30 (T2) and Day 60 (T3) in Tear Film Break-Up Time (TFBUT) values, following treatment with BLUgel A free ophthalmic solution in patients with mild dry eye syndrome.
  • Changes from baseline (T0) to Day 60 (T3) in Tear Film Break-Up Time (TFBUT) values, following treatment with BLUyal A free ophthalmic solution in patients with mild dry eye syndrome.

The TFBUT will be measured twice during the first minute after the instillation of the fluorescein. If the 2 readings differ by more than 2 seconds a third reading will be taken. The TFBUT value will be the average of the 2 or 3 measurements.
Day 30 and Day 60
Efficacy Assessment from baseline
大体时间：Day 30 and Day 60

Change from baseline (T0) to Day 30 (T2) and Day 60 (T3) in non-invasive Break-Up Time (niBUT) measured via Tearcheck®, following treatment with BLUgel A free, and with BLUyal A free ophthalmic solution. niBUT evaluates the stability and the break-up time of the tear film. In particular, niBUT shows site and time of ruptures of the tear film. During a 10-second imaging, Tearcheck® evaluates the tear film surface 3 times per second. For better readability, results are then grouped into 2-second increments. niBUT will be expressed in seconds.
Day 30 and Day 60
Change in non-invasive Break-Up Time (niBUT) from baseline
大体时间：Day 30 and Day 60

Change from baseline (T0) to Day 30 (T2) and Day 60 (T3) in non-invasive Break-Up Time (niBUT) measured via Tearcheck®, following treatment with BLUgel A free, and with BLUyal A free ophthalmic solution. niBUT evaluates the stability and the break-up time of the tear film. In particular, niBUT shows site and time of ruptures of the tear film. During a 10-second imaging, Tearcheck® evaluates the tear film surface 3 times per second. For better readability, results are then grouped into 2-second increments. niBUT will be expressed in seconds.
Day 30 and Day 60
Assessment of Tear meniscus height after treatment compared to baseline
大体时间：Day 30 and Day 60

Change from baseline (T0) to Day 30 (T2) and Day 60 (T3) of conjunctival, measured via Tearcheck®, following treatment with BLUgel A free and with BLUyal A free ophthalmic solution.

The Tearcheck® instrument will be used to measure niBUT, tear meniscus height, conjunctival hyperaemia and meibography, which will not be performed at Visit 2-T1 (Day 15 +3); all the remaining parameters will be measured at any visit.

The tear meniscus will be evaluated in the lower eyelid and shows, if there is sufficient tear production before the next eye blink. Two values will be calculated: 1) tear meniscus measurement below iric centre; 2) thickest measurement of the tear meniscus. The tear meniscus height will be expressed in millimetres.
Day 30 and Day 60
Assessment of conjunctival hypaermia from baseline
大体时间：Day 30 and Day 60

Change from baseline (T0) to Day 30 (T2) and Day 60 (T3) in conjunctival hypaermia, measured via Tearcheck®, following treatment with BLUgel A free and with BLUyal A free ophthalmic solution. niBUT evaluates the stability and the break-up time of the tear film.The Tearcheck® instrument will be used to measure niBUT, tear meniscus height, conjunctival hyperaemia and meibography, which will not be performed at Visit 2-T1 (Day 15 +3); all the remaining parameters will be measured at any visit.
Day 30 and Day 60
Assessment of possible changes in meibomian gland from baseline
大体时间：Day 30 and Day 60

Change from baseline (T0) to Day 30 (T2) and Day 60 (T3) in meibography, measured via Tearcheck®, following treatment with BLUgel A free and with BLUyal A free ophthalmic solution. Meibography makes it possible to visualize the meibomian glands. This visualization is useful in explaining the anatomical structure responsible for the production of the lipid film to the patient. The result will be expressed as percentage of loss of glands compared to an individual with all of the glands present.
Day 30 and Day 60
Assessment of total tear secretion from baseline
大体时间：Day 30 and Day 60

Change from baseline (T0) to Day 30 (T2) and Day 60 (T3) in Schirmer's Test I values following treatment with BLUgel A free and with BLUyal A free ophthalmic solution.

The Schirmer's test I (Schirmer, 1903) measures the quantity of total tear secretion, including reflex and basal tears, which are produced by the eye. A 35 mm x 5 mm size filter paper strip is used to measure the amount of tears that are produced over a period of 5 minutes. Without instilling anaesthetic drops, the Schirmer strips are inserted into the eye under the eyelid and into the lower conjunctival fornix near the lateral corner, avoiding contact with the cornea. The paper strip remains in the conjunctival fornix for 5 minutes to measure the production of tears. The wet portion of the strip is measured in millimetres. The test is done under ambient light. The patient is instructed to look forward and to blink normally during the course of the test.
Day 30 and Day 60
Assessment of impact of Dry Eye on Everyday Life (IDEEL) from baseline
大体时间：Day 30 and Day 60

Change from baseline (T0) to Day 30 (T2) and Day 60 (T3) in score of Impact of Dry Eye on Everyday Living (IDEEL) questionnaire ("Dry Eye Symptom-Bother" module) following treatment with BLUgel A free and with BLUyal A freeophthalmic solution. The Impact of Dry Eye on Everyday Life (IDEEL) questionnaire is a comprehensive dry eye specific questionnaire developed to evaluate symptom-related bother, impact on daily life and treatment satisfaction in a population with dry eye (Abetz et al, 2011). There are 57 items grouped into 3 different modules: i) the Dry Eye Impact on Daily Life" (3 section: daily living activities (9 items), emotional impact (12 items) and impact of work (6 items); ii) the "Dry Eye Symptom-Bother" (20 items), and iii) the "Dry Eye Treatment Satisfaction" (10 items). Only the "Dry Eye Symptom-Bother" (10 items) will be evaluated in this investigation
Day 30 and Day 60
Incidence and nature of treatment-emergent adverse events
大体时间：Day 30 and Day 60

Incidence and nature of treatment-emergent adverse events (TEAEs) as well as of the treatment-emergent serious adverse events (TESAEs); Incidence and nature of the Adverse Device Effects (ADEs); Incidence and nature of the Serious Adverse Device Effects (SADEs); Incidence and nature of Investigational Medical Device Deficiencies (IMDDs)
Day 30 and Day 60

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fidia Farmaceutici s.p.a.

调查人员

  • 首席研究员：Rita Mencucci, MD、AOU Careggi

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年6月21日

初级完成 (实际的)

2024年10月30日

研究完成 (实际的)

2024年12月4日

研究注册日期

首次提交

2023年12月1日

首先提交符合 QC 标准的

2023年12月19日

首次发布 (实际的)

2024年1月3日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IS01-21-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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