Multicentric Clinical Investigation on the Use of Single-dose Ophthalmic Solution Based on Hyaluronate Sodium Phosphate in the Treatment of Eye Discomfort in Particular in Case of Ocular Dryness
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Ocular Dryness
- 发起方
- SIFI SpA
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Tear Film Break-up Time With Fluorescein (TFBUT)
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
The purpose of this study is to assess the performance and safety resulting from the treatment of an ophthalmic solution for the ocular discomfort and in particular in presence of ocular dryness.
详细描述
Multicenter, prospective, observational, open-label, non- interventional clinical investigation evaluating the performance and safety of 4 daily instillations of the ophthalmic solution in the treatment of mild irritation of the ocular surface.
研究者
入排标准
入选标准
- •Subjects (male or female) must be ≥ 18 years of age;
- •Subject able to provide Informed Consent, in compliance with the 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 mild to moderate dry eye in one or both eyes determined by:
- •Scoring of ocular surface staining with fluorescein using the National Eye Institute (NEI) scale. Total score per single eye range 6-33 summing the score of cornea and conjunctiva. (Considering a normal score of 0-33);
- •Tear film break-up time with fluorescein (TFBUT) ≤ 10 seconds; The TFBUT value will be recorded as the average of 3 measurements;
- •Symptom Assessment in Dry Eye (SANDE) questionnaire ≥
- •Subject able to be compliant with the requirements of the clinical investigation plan, according to the Investigator;
- •Subject who qualifies for Hyalistil Bio PF treatment according to the approved indication;
- •Subject who in physician's opinion will benefit from this treatment.
排除标准
- •Corneal injuries or abrasions of traumatic origin in the eye of study;
- •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;
- •Systemic lupus erythematosus;
- •Pathologies associated with corneal thinning;
- •Taking drugs that may interfere with tear gland secretion (beta -blockers);
- •Patients using any topical therapies such as non-steroidal antiinflammatory drugs, cortisone, cyclosporine, vasoconstrictor, artificial tears (different than the investigated product) the eye of study;
- •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.
结局指标
主要结局
Tear Film Break-up Time With Fluorescein (TFBUT)
时间窗: Evaluated at Visit 1 (baseline) and Visit 3 (day 35 ± 4 - study termination)
The TFBUT will be performed after instillation of 5 microliters of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient will be instructed to blink several times to thoroughly mix the fluorescein with the tear film. To achieve maximum fluorescence, the examiner should wait approximately 30 seconds after instillation before evaluating TFBUT. The TFBUT was measured by determining the time in seconds to tear break-up within 10 seconds maximum, and it was measured three time during the first minute after the instillation of fluorescein solution. The TFBUT value will be the average of 3 measurements.
次要结局
- Fluorescein Staining(Evaluated at Visit 1 (baseline), Visit 2 (day 14± 2) and Visit3 (day 35 ± 4 - study termination visit))
- SANDE(Evaluated at Visit 1 (baseline), Visit2 (day 14± 2) and Visit3 (35 ± 4 - study termination))
- Evaluation of the Degree of Satisfaction to the Treatment Reported by Patients Through the Use of the Visual Analogue Scale (VAS).(Evaluated at day 35 ± 4 of treatment)
- Dry Eye-Related Quality of Life (DEQS Total Score)(Baseline (Visit 1) and Study Termination Visit (Day 35 ± 4))
- Tear Film Break-up Time With Fluorescein (TFBUT)(Evaluated at day 14 ± 2 of treatment (Visit 2) and day 35 ± 4 of treatment (Visit 3 - Study termination))
- Best Corrected Visual Acuity (BCVA)(Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline)