The Clinical Performance of the Clariti Contact Lens (Including Handling Tint) for Daily Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Slit lamp Biomicroscopy
研究概览
简要总结
The purpose of this study was to investigate the safety and efficacy of the Sauflon Clariti Monthly silicone hydrogel contact lenses with handling tint (Sauflon Pharmaceuticals Limited) by comparison with Air Optix Aqua silicone hydrogel lenses (Alcon Inc.)
Subjects used OptiFree Replenish solution (Alcon Lboratories Inc.) for daily lens maintenance, care and storage.
详细描述
I. Study characteristics:
The clinical study evaluates the clinical performance of a silicone hydrogel contact lens for daily wear, Clariti (including handling tint) (Sauflon Pharmaceuticals Ltd.) versus a predicate device, Air Optix Aqua (Alcon Inc.), in terms of lens performance, physiological response and subjective acceptance.
Subjects used OptiFRee Replenish solution (Alcon Laboratories Inc.) for daily lens maintenance, care and storage.
The key features were as follows:
- One month duration.
- Three investigator sites.
- Daily wear soft (hydrophilic) silicone hydrogel contact lenses, replaced on a monthly basis: Clariti Monthly (with handling tint)and Air Optix Aqua. Replenish was used as a care system by all subjects.
- A total of 38 subjects were enrolled, and 38 subjects accounted for 76 eyes were dispensed lenses. This group was randomized into 25 test subjects (50 eyes) and 13 control subjects (26 eyes).
- Of the 25 test subjects, 25 (100%) completed one month of use. Of the 13 control subjects, 12 (92.3%)completed one month of use.
- There were no adverse reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They are 18 years of age and above
- •They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent
- •They are willing and able to follow the protocol
- •The agree not to paticipate in other clinical research for the duration of this study
- •They have a best spectacle corrected visual acuity greater or equal to 20/25 (logMAR 0.1)
- •They have a manifest cylinder less than or equal to 0.75D
- •They have successfully worn contact lenses within six months of starting the study
- •They can be fitted with spherical soft contact lenses within the power range available
- •They are willing to wear the study lenses for a minimum of four days a week, six hours a day
排除标准
- •They have any active anterior segment ocular disease which would normally contraindicate contact lens wear
- •They have any anterior segment infection, inflammation or abnormality
- •They use any systemic medications which would normally contraindicate contact lens wear
- •They are using any ocular medications
- •They have a history of herpetic keratitis
- •They have a systemic disorder which would normally contraindicate contact lens wear
- •They have any infectious disease (e.g. Hepatitis) or any immunosuppressive disease (e.g. HIV)
- •They have glaucoma (high pressure in the eye), have had cataract surgery or a history of recurring abrasions
- •They have had corneal refractive surgery or they have an irregular cornea
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus
- •They are pregnant or lactating
- •They have any slit lamp findings which are more serious than grade 1
- •They have a history of anaphylaxis or severe allergic reactions
- •They have taken part in any other contact lens or contact lens care product clinical trial or research, within two weeks prior to starting this study
结局指标
主要结局
Slit lamp Biomicroscopy
时间窗: 1 month
Slit Lamp examination will be performed at the initial and follow-up visits. Slit lamp findings will be graded on a 0-4 scale (0=none;4=severe).
Adverse reactions
时间窗: 1 month
Adverse reactions will be recorded throughout the study. Adverse recations will be classified as serious, significant and non-significant.
Wear Time
时间窗: 1 month
Lens wear time is recorded for the two study lenses at follow-up visits.
Visual Acuity
时间窗: 1 month
LogMAR Visual Acuity at high contrast will be recorded before and after performeing an over-refraction at the initial, two-week and one-month visits.
次要结局
- Subjective Scores(1 month)
- Symptoms, problems and complaints(1 month)
- Discontinuations(1 month)
- Refraction(1 month)
- Keratometry(1 month)