One Month Daily Wear Clinical Evaluation of Three Prototype Soft Contact Lenses in a Population of Habitual and Neophyte Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Corneal Staining (Area)
研究概览
简要总结
There will be four study lenses tested; one marketed lens, and three prototype study lenses. Subjects will be randomized to one of the four study lenses which will be worn in a daily wear modality, with a two week replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must be between 18 and 39 years of age.
- •The subject must be able to read and understand English.
- •The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- •The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days.
- •The subject must be willing to wearthe study lenses for at least 6 hours per day, 7 days per week (e.g. does not regularly swim).
- •The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol.
- •The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -4.00D in each eye.
- •The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes.
- •The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye.
- •The subject must require a visual correction in both eyes (no monofit or monovision allowed).
- •The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •No amblyopia
- •No evidence of lid abnormality or infection (including blepharitis/meibomitis)
- •No conjunctival abnormality or infection.
- •No clinically significant slit lamp findings (i.e. stromal edema, vascularization, corneal scaring, infiltrates or abnormal opacities).
- •No other active ocular diseases.
排除标准
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any systemic diseases, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- •Clinically significant (Grade 3 or 4) corneal edeam, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid permeable contact lens wear.
- •Pregnancy or lactation (subjects who become pregnant during the study will be discontinued).
- •No extended wear in the last 3 months.
- •Infectious diseases (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
- •Has had refractive surgery.
- •Employee of VRF with direct involvement in the study or a family member of the clinic.
研究组 & 干预措施
etafilcon A
Marketed control soft contact lens
干预措施: ACUVUE 2 (Device)
Prototype E1
Investigational soft contact lens
干预措施: Prototype E1 (Device)
Prototype E2
Investigational soft contact lens
干预措施: Prototype E2 (Device)
Prototype E3
Investigational soft contact lens
干预措施: Prototype E3 (Device)
结局指标
主要结局
Corneal Staining (Area)
时间窗: Baseline and 4-Week Follow-up
Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. Grade 0= 0% of region covered, Grade 1 =10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4= 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered,Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered and Grade 10 = 100% of region covered). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.
Limbal Conjunctival Redness
时间窗: Baseline and 2-Week Follow-up
Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.
Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation)
时间窗: Baseline and 4-Week Follow-up
The Ocular symptom Grittiness/Foreign Body Sensation was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness)
时间窗: Baseline and 4-Week Follow-up
The Ocular symptom Itchiness/Scratchiness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Percentage of Reported Ocular Symptoms (Redness)
时间窗: Baseline and 4-Week Follow-up
The Ocular symptom Redness wasassessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Percentage of Reported Ocular Symptoms (Irritation/Discomfort)
时间窗: Baseline and 4-Week Follow-up
The Ocular symptom Irritation/Discomfort was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Percentage of Reported Ocular Symptoms (Variable Vision)
时间窗: Baseline and 4-Week Follow-up
The Ocular symptom Variable Vision was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Corneal Edema
时间窗: Baseline and 4-Week Follow-up
Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Conjunctival Injection
时间窗: Baseline and 4-Week Follow-up
Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Corneal Neovascularization
时间窗: Baseline and 4-Week Follow-up
Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Tarsal Abnormalities
时间窗: 1-, 2- and 4-Week Follow-up
Tarsal abnormalities were assessed using a biomicroscope at baseline, post lens fitting, 1-, 2- and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0, 1, 2, 3 and 4) with grade 0 represents the absence of abnormalities and 1 to 4 representing successively worse abnormalities (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The percentage of eyes with Grade 3 or higher was reported.
Percentage of Reported Ocular Symptoms (Lens Awareness)
时间窗: Baseline and 4-Week Follow-up
The Ocular symptom Lens awareness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Corneal Staining (Depth)
时间窗: Baseline and 4-Week Follow-up
Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e. Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.
Corneal Staining (Type)
时间窗: Baseline and 4-Week Follow-up
Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.
Bulbar Conjunctival Redness
时间窗: Baseline and 2-Week Follow-up
Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.
Lens Fitting Characteristics
时间窗: Post Lens Fitting and 4-Week Follow-up
Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations. Lens fit is a binary response as acceptable or unacceptable lens fit. The percentage of eyes with acceptable lens fit was reported.
Percentage of Reported Ocular Symptoms (Burning/Stinging)
时间窗: Baseline and 4-Week Follow-up
The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Visual Acuity (LogMAR)
时间窗: 4-Week Follow-up
Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported.
Corneal Staining
时间窗: Baseline and 4-Week Follow-up
Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy)
时间窗: Baseline and 4-Week Follow-up
The Ocular symptom Cloudy/Blurry/Hazy was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Percentage of Reported Ocular Symptoms (Dryness)
时间窗: Baseline and 4-Week Follow-up
The Ocular symptom Dryness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
次要结局
未报告次要终点