Multicentric Clinical Investigation on the Use of Preservative-Free Ophthalmic Solution Based on Sodium Hyaluronate and Xanthan Gum in the Treatment of Eye Discomfort, in Particular in Case of Ocular Dryness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SIFI SpA
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Keratitis lesions
研究概览
简要总结
This is a multicenter, prospective, observational, open-label, non-interventional study evaluating the clinical performance and the safety of 4 daily instillations of the ophthalmic solution in the treatment of eye discomfort, in particular due to eye dryness
详细描述
Primary objective
▪ To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline.
Secondary objectives
-
To evaluate the mean change of the corneal and conjunctival staining score with fluorescein using the NEI scale after 14 days of treatment and after 3 months of treatment compared to baseline.
-
To evaluate conjunctival hyperemia index assessed by OCULUS Keratograph after 14 days, 1 month and 3 months of treatment compared to baseline.
-
To evaluate the tear film stability as objectified by the tear film break-up time (TFBUT) test after 14 days, 1 month and 3 months of study treatment initiation compared to baseline.
-
To evaluate the changes on the Best Corrected Visual Acuity (BCVA) measured by the "Early Treatment Diabetic Retinopathy Study" (ETDRS) after 14 days, 1 month and 3 months of study treatment initiation compared to baseline.
-
To compare patients reported outcomes with baseline, using specifically:
-
the patient's reported Symptom Assessment questionnaire iN Dry Eye (SANDE) after 1 and 3 months of treatment;
-
the patient's Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire after 1 and 3 months of treatment.
-
To evaluate the safety and compliance of the medical device throughout the entire study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Male or female subjects aged 18 years or older
- •Subject able to provide Informed Consent, in compliance with Good Clinical Practice and local laws (thus, subject able to comprehend the full nature and purpose of the study, including possible risks and side effects)
- •Subjects with ocular discomfort resulting from eye dryness in one or both eyes as determined by:
- •Scoring of ocular surface staining with fluorescein using the NEI scale (summing the score of cornea and conjunctiva, the total score per single eye range should be at least ≥6 on the 0-33 NEI scale)
- •TFBUT with fluorescein ≤10 seconds. The TFBUT value will be recorded as the average of 3 measurements
- •SANDE questionnaire ≥35
- •Subject able to comply with the requirements of the clinical investigation plan, according to the Investigator
排除标准
- •Corneal injuries or abrasions of traumatic origin
- •Ocular infection or clinically significant inflammation (such as Herpes Simplex infection, corneal virus infection, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye)
- •Sjögren's syndrome
- •Stevens-Johnson syndrome
- •Concomitant treatment with drugs that may interfere with tear gland secretion
- •Patients using any topical therapies such as non-steroidal anti-inflammatory drugs, cortisone, cyclosporine, vasoconstrictor, artificial tears (different than the investigated product)
- •Treatment with topical or systemic corticosteroids in the 4 weeks preceding the study
- •Known or potential hypersensitivity and/or history of allergic reactions to one of the components of the topical medical device
- •Participation in another clinical trial within the previous 30 days
- •Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the Investigator does not allow the participation in the study or could compromise the results
- •Pathologies associated with corneal thinning
结局指标
主要结局
Keratitis lesions
时间窗: 1 month
To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline.
次要结局
- Tear Film Stability Break-Up time(Day 14, 1 month and 3 months)
- Conjuctival Hyperemia(Day 14, 1 month and 3 months)
- DEQS Questionnaire(1 and 3 months)
- Keratitis Lesions(Day 14 and at 3 months)
- Best Corrected Visual Acuity(Day 14, 1 month and 3 months)
- Number of Adverse Events(From date of randomization up to 3 months)
- Investigator Global Assessment Score(From date of randomization up to 3 months)
- Intra Ocular Pressure(From date of randomization up to 3 months)
- SANDE Questionnaire(1 and 3 months)
- Number and status (empty/unused) of returned devices(Day 14, 1 month and 3 months)