NCT07322211招募中不适用
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Total suspended eye(s)
研究概览
简要总结
13 weeks, open-label, daily disposable contact lens dispensing study.
详细描述
The purpose of this clinical study is to evaluate the safety and clinical performance of the investigational soft contact lens when worn in a daily wear modality, by assessing total suspended eye(s) as the primary variable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult with an age ≥ 18;
- •Be a currently adapted soft contact lens wearer who successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 6 hours per day within 3 months prior to study screening (by verbal confirmation);
- •Participant must be stop wearing any contact lenses more than 7 days prior to screening;
- •Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes;
- •Astigmatism of 1.25D or less in both eyes;
- •Be correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye;
- •Participant must be able to be successfully fit with study lenses;
- •The participant must appear able and willing to adhere to the instructions set forth in this clinical protocol;
- •The participant must read and sign the Informed Consent Form.
排除标准
- •Women who are currently pregnant;
- •Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit);
- •Any use of systemic or ocular medications (e.g., non-steroidal anti-inflammatory eye drops, ophthalmic steroids) within 30 days prior to study enrollment for which contact lens wear could be contraindicated, as determined by the investigator;
- •Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator;
- •Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study;
- •Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) or planned for ocular and/or refractive surgery during the study;
- •Current or history of herpetic keratitis in either eye;
- •Current or history of intolerance, hypersensitivity or allergy to silicone hydrogel soft contact lenses or any component of the study products;
- •Current clinical finding of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye (defined as Schirmer test < 5 mm/5 min), recurrent corneal erosions, aphakia, or moderate or above corneal distortion;
- •Employee of Department of Ophthalmology and clinic (e.g., Investigator, Coordinator, Technician);
- •Participation in any interventional clinical trial within 30 days prior to study enrollment;
- •Any biomicroscopy findings at screening that are Grade 3 or higher and/or corneal neovascularization that is Grade 2 or higher and/or presence of corneal infiltrates;
- •Any history of a contact lens-related corneal inflammatory or infectious event within 12 months prior to study enrollment that may contraindicate contact lens wear;
- •Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
- •Participants are considered ineligible for the study as judged by the investigator.
研究组 & 干预措施
Open-label, single-arm, dispensing study.
Experimental
Qualis (linofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
干预措施: Treatment (Device)
结局指标
主要结局
Total suspended eye(s)
时间窗: From enrollment to the end of treatment at 13 weeks
To evaluate the safety of study lenses by the total suspended eye(s) occurrence rate during the study period.
次要结局
- Tabulation of Discontinued Eye(s)(From enrollment to the end of treatment at 13 weeks)
- Tabulation of Subjective Symptoms(From enrollment to the end of treatment at 13 weeks)
- Tabulation of Slit-Lamp Microscopy Findings(From enrollment to the end of treatment at 13 weeks)
- Tabulation of Adverse Event(s)(From enrollment to the end of treatment at 13 weeks)
- Tabulation of Adverse Device Effect(s)(From enrollment to the end of treatment at 13 weeks)
- Tabulation of Device Deficiencies(From enrollment to the end of treatment at 13 weeks)
- Contact Lens Corrected Visual Acuity(From enrollment to the end of treatment at 13 weeks)
- Mean of Contact Lens Corrected Visual Acuity(From enrollment to the end of treatment at 13 weeks)
研究者
研究点 (2)
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