Clinical Trial for the Evaluation of the Safety and Efficacy of a Moisturizing Solution With Hyaluronic Acid Drop 0.4%
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 79
- 主要终点
- Changes in best corrected visual acuity (safety outcome)
研究概览
简要总结
The aim of the trial is to compare the safety and efficacy of the moisturizing solution DROP 0.4% with the moisturizing solution AVIZOR EYE DROPS 0.2% PRESERVED in relieving the symptoms of dry eye over one month of use.
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)
盲法说明
Product and comparator have the same external and physical characteristics and the label is the same for both products except for expiry date
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 years or older, capable of freely providing informed consent for participation in the study.
- •Signed informed consent form prior to any study-related tests.
- •Signed data protection form prior to any study-related tests.
- •Additionally, for Group 1 (Non contact lens users)
- •Ocular surface disease index (OSDI) ≥ 13
- •No use of contact lenses in the past month and not planning to use them during the study period.
- •Additionally, for Group 2 (contact lens users)
- •Contact lens dry eye questionnaire (CLDEQ-8) ≥ 12
- •Contact lens (CL) use with a habitual minimum use of 4 days per week and 4 hours per day in the past month.
排除标准
- •Any active ocular surface disease except for dry eye disease.
- •Severe dry eye, defined as meeting at least one of the following criteria in at least one eye:
- •Corneal fluorescein staining ≥ 4 on the Oxford scale (0-5).
- •Conjunctival lissamine green staining ≥ 4 on the Oxford scale (0-5).
- •Schirmer test value ≤ 2 mm.
- •Tear stability (BUT) of 0 seconds.
- •History of ocular surgery in the last 3 months or refractive corneal surgery in the last 6 months.
- •History of herpetic keratitis or uveitis.
- •History of severe ocular infections or inflammation in the 6 months prior to the study.
- •History of allergies affecting the ocular surface during the study period.
- •Patients who have started or are expected to modify the use of the following topical medications during the study (except for artificial tears/moisturizing and lubricating solutions):
- •Calcineurin inhibitors (cyclosporine, tacrolimus, etc.) in the 12 weeks prior to the study.
- •Corticosteroids or non steroid anti-inflammatory drugs (NSAID) in the 4 weeks prior to the study.
- •Blood-derived treatments (autologous serum, enriched plasma, etc.), insulin, or amniotic preparations in the week prior to the study.
- •Use of systemic medication with potential effects on the tear film that has been started or modified in the last month or is expected to change during the study.
- •Known sensitivity or intolerance to any of the products used in the study.
- •Subjects with clinically relevant or uncontrolled systemic diseases in the last 3 months that may interfere with study assessments or outcomes.
- •Pregnancy or breastfeeding. Lack of effective contraceptive methods in women of childbearing potential.
- •Participation in a clinical trial within the last 30 days.
研究组 & 干预措施
Contact lens users with eye dryness
Contact lens users that have eye dryness symptoms. Both treatments will be administered, as it is a crossover study.
干预措施: Multidose mosturizing solution DROP 0.4% (Device)
Contact lens users with eye dryness
Contact lens users that have eye dryness symptoms. Both treatments will be administered, as it is a crossover study.
干预措施: Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved (Device)
Non contact lens user with eye dryness
Non contact lens patients with eye dryness symptoms. Both treatments will be administered, as it is a crossover study.
干预措施: Multidose mosturizing solution DROP 0.4% (Device)
Non contact lens user with eye dryness
Non contact lens patients with eye dryness symptoms. Both treatments will be administered, as it is a crossover study.
干预措施: Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved (Device)
结局指标
主要结局
Changes in best corrected visual acuity (safety outcome)
时间窗: 1 month
Best corrected visual acuity tested with ETDRS (early treatment for diabetes retinopathy study).
Changes in eye dryness symptoms
时间窗: 1 month
Changes in ocular symptoms (measured with Contact lens dry eye questionnaire and/or change in the frequency and intensity of dry eye symptoms (measured with a Visual analogue scale from 0 to 10). For contact lens users
Serious adverse events
时间窗: 1 month
All local and systemic serious adverse events
Ocular and peri orbital adverse events
时间窗: 1 month
All local adverse events reported
次要结局
- Tear evaporation(1 month)
- Number of instillations per product(1 month)
- User satisfaction with the product(1 month)
- Stability of the tear film(1 month)
- Ocular surface response to treatment - Oxford Scale (0 (Better) to 5 (Worse))(1 month)