NCT05191771Unknown不适用
Multicentric, Randomized, Comparative Clinical Study on the Evaluation of the Efficacy and Safety of Neovis® Total Multi Versus Systane® Balance on the Treatment of Ocular Dryness Associated With Meibomian Gland Dysfunction
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Horus Pharma
- 入组人数
- 120
- 主要终点
- Tear-Film Break Up Time (TBUT)
研究概览
简要总结
This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of improvement of stability of Tear film in patients with eye dryness associated to meibomian gland dysfunction, after 28 days of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Presenting dry eye symptoms for at least 6 months.
- •OSDI (Ocular Surface Disease Index) ≥ 18
- •At least one eye eligible with:
- •sum of peripheral corneal and conjunctival staining ≥ 4 and ≤ 9 (Oxford 0-15 grading scheme) AND
- •sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 15s
- •Meibomian Gland Dysfunction on at least one eye (same eye eligible) with a score of 1 or higher for meibum quality score (from 0: clear to 3: toothpaste/obstruction) and evidence of partial or whole missing Meibomian Glands.
- •Ability and willingness to apply eyelid hygiene during the whole study, including wash-out period.
- •Having given freely and expressly his/her informed consent.
- •Able to comply with the study requirements, as defined in the present CIP, at the Investigator's appreciation.
- •In France: subject being affiliated to a health social security system.
- •Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
排除标准
- •Pregnant or nursing woman or planning a pregnancy during the study.
- •Subject deprived of freedom by administrative or legal decision.
- •Subject in a social or health institution
- •Subject who is under guardianship or who is not able to express his/her consent.
- •Use of contact lenses in either eye during the study.
- •Far best-corrected visual acuity ≤ 1/
- •Subject with severe ocular dryness with one of these conditions:
- •Eyelid or blinking malfunction
- •Corneal disorders not related to dry eye syndrome
- •Ocular metaplasia
- •Filamentous keratitis
- •Corneal neovascularization
- •History of ocular traumatism, ocular infection or ocular inflammation within the last 3 months.
- •History of ocular allergy or ocular herpes within the last 12 months.
- •Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months.
- •Any troubles of the ocular surface not related to dry eye syndrome.
- •Use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus during the month preceding the inclusion.
- •IOP > 21 mmHg
- •Uncontrolled systemic disease
- •Alcohol abuse
- •Psychiatric disorders
- •Cognitive impairment that could affect evaluation of preferences or inability to understand written patient information
- •Participation in other clinical studies in the last month
- •Hypersensitivity to one or more components of the study product
- •Dry eye due to systemic disease, concomitant medication, malign conditions or idiopathic causes
- •Punctual plugs during the past 3 months
- •Use of lipid-containing eye drops during the past 3 months
- •Use of other therapeutic ophthalmics during the past 3 months
- •Earlier participation at this clinical trial or the patient being an investigator or a member of the personnel involved at this clinical trial
结局指标
主要结局
Tear-Film Break Up Time (TBUT)
时间窗: 28 days
Evaluation of the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of TBUT improvement, on worse eye
次要结局
- Eyelid margin abnormalities (performance)(84 days)
- OSDI (questionnaire) (performance)(84 days)
- Meibomian gland expression (performance)(84 days)
- Meibum quality (performance)(84 days)
- Meiboscopy (performance)(84 days)
- Tear-Film Break Up Time (TBUT) (performance)(84 days)
- Cornea and conjunctiva staining (Oxford score) (performance)(84 days)
- Global performance by the patient (performance)(84 days)
- Global tolerance by the patient (safety)(84 days)
- Number of Adverse Events(84 days)
- Global performance by the investigator (performance)(84 days)
- Global tolerance by the investigator (safety)(84 days)
- Intensity of ocular symptoms upon instillation (safety)(84 days)
- Duration of ocular symptoms upon instillation (safety)(84 days)
- Frequency of ocular symptoms upon instillation (safety)(84 days)
研究者
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