Multicenter Dispensing Study of Biofinity Lenses in Extended Range
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Handling (Insertion, Removal, Overall)
研究概览
简要总结
To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.
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 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has had an oculo-visual examination in the last two years
- •Is at least 18 years of age and has full legal capacity to volunteer
- •Has read and understood the information consent letter
- •Is willing and able to follow instructions and maintain the appointment schedule
- •Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their habitual vision correction
- •Currently wears soft contact lenses
- •They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
- •Has clear corneas and no active ocular disease
- •Demonstrates an acceptable fit with the study lenses.
排除标准
- •Has any systemic disease affecting ocular health
- •Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
- •Have any active ocular disease and/or infection that would contraindicate contact lens wear.
- •Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
- •Has worn gas permeable contact lenses within the last month.
- •Is aphakic
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of clinical research study
- •Female who is currently pregnant or is breast-feeding.
研究组 & 干预措施
Biofinity XR
Participants dispensed Biofinity XR lenses over two weeks of lens wear
干预措施: Biofinity XR (Device)
结局指标
主要结局
Handling (Insertion, Removal, Overall)
时间窗: 2 weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
Vision Quality (During Day)
时间窗: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Vision Preference
时间窗: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Dryness (During Day and Dryness at Night)
时间窗: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.
Dryness (During Day)
时间窗: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Comfort (Insertion, End of Day, Overall)
时间窗: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
Handling Preference
时间窗: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Comfort (Insertion)
时间窗: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Hazing (Blurred Edges)
时间窗: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.
Ghosting (Multiple Images)
时间窗: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.
Vision Quality (During Day and at Night)
时间窗: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.
Comfort Preference
时间窗: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Overall Preference
时间窗: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Overall Satisfaction of Comfort, Vision, Handling
时间窗: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.
Dryness (During Day and Dryness at Night)
时间窗: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.
Comfort (Insertion, End of Day, Overall)
时间窗: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Ghosting (Multiple Images)
时间窗: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.
Ghosting (Multiple Images)
时间窗: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Hazing (Blurred Edges)
时间窗: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.
Vision Quality (During Day and at Night)
时间窗: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.
Handling (Insertion, Removal, Overall)
时间窗: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Overall Satisfaction of Comfort, Vision, Handling
时间窗: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Overall Satisfaction of Comfort, Vision, Handling
时间窗: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.
Comfort Preference
时间窗: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Vision Preference
时间窗: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Overall Preference
时间窗: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
次要结局
- Lens Centration - Habitual Lenses(Baseline)
- Overall Fit Acceptance(2 Weeks)
- Anterior Ocular Physiological Response(2 Weeks)
- Lens Centration(2 Weeks)
- Lens Movement(2 Weeks)
- Average Wearing Time(2 Weeks)
- Lens Movement - Habitual Lenses(Baseline)
- Visual Acuity(2 Weeks)
- Lens Centration(Dispense)
- Lens Movement(Dispense)
- Overall Fit Acceptance(Baseline)
- Overall Fit Acceptance(Dispense)
- Visual Acuity(Baseline)
- Visual Acuity(Dispense)
- Anterior Ocular Physiological Response(Baseline)
- Average Wearing Time(Baseline)