Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 21
- 主要终点
- Distance (4m) Monocular High Luminance High Contrast (HLHC) logMAR Visual Acuity (VA)
研究概览
简要总结
This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Be between 18 and 39 (inclusive) years of age at the time of screening.
- •By self-report, habitually wear soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per week during last 30 days.
- •Possess a wearable pair of spectacles that provide correction for distance vision.
- •In both eyes, have astigmatic refractive error suitable for correction with the toric contact lens powers available in this study:
- •Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps
- •Cylinder powers (DC) -0.75 and -1.25
- •Axes (°) 170, 180, 10, 80, 90, 100
- •Have best corrected monocular distance visual acuity of 20/30 or better in each eye.
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Be currently pregnant or lactating.
- •Be diabetic.
- •Be currently using any ocular medications or have an ocular infection of any type.
- •By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
- •Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
- •Be currently wearing monovision or multifocal contact lenses.
- •Be currently wearing lenses in an extended wear modality.
- •Have a history of strabismus or amblyopia.
- •Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- •Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- •Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
- •Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- •Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, Photorefractive Keratectomy [PRK], Laser-Assisted in Situ Keratomileusis [LASIK], iridotomy, retinal laser photocoagulation, etc.).
排除标准
- 未提供
研究组 & 干预措施
Control/Test
Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens followed by the Test Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.
干预措施: Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent. (Device)
Control/Test
Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens followed by the Test Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.
干预措施: ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent. (Device)
Test/Control
Eligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens followed by the Control Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.
干预措施: Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent. (Device)
Test/Control
Eligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens followed by the Control Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.
干预措施: ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent. (Device)
结局指标
主要结局
Distance (4m) Monocular High Luminance High Contrast (HLHC) logMAR Visual Acuity (VA)
时间窗: At each 1-week follow-up per wear period
VA will be assessed monocularly under HLHC conditions at a test distance of 4 meters using ETDRS Charts.
Toric Lens Orientation
时间窗: At baseline per wear period
Toric lens orientation (scribe mark position relative to 6 o'clock) will be assessed for each eye at 15 minutes after lens insertion. Toric lens orientation will be used to define a binary endpoint, i.e. the percentage of eyes that achieve absolute toric lens rotation ≤ 10°.
Lens Rotational Stability with Blinks
时间窗: At baseline per wear period
Rotational stability will be assessed for each eye at least 15 minutes after lens insertion. Lens rotational stability with blinks will be defined as a binary endpoint, the percentage of eyes that achieve rotational stability with blinks ≤ 5°.
Percentage of eyes with Grade 3 or higher SLFs relating to the test lens
时间窗: Up to 3-week follow-up
SLFs (Grade 3 or higher) related to study lens wear for the test lens will be assessed for each eye at all study visits (scheduled and unscheduled). SLFs will be evaluated and graded using the FDA Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings. The percentage of eyes with Grade 3 or higher SLF will be analyzed and will include corneal infiltrates.
Percentage of eyes with acceptable lens fitting while wearing the test lens
时间窗: Up to 3-week follow-up
Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye and used to define a binary endpoint, i.e. the percentage of eyes that achieve acceptable lens fit while wearing the test lens. Lens fit will be deemed unacceptable if any one of the following criteria are met: * limbal exposure at primary gaze or with extreme eye movement. * edge lift. * excessive movement on blink in primary gaze. * insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.
Distance Monocular logMAR Visual Acuity
时间窗: 1-Week Follow-up
Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
时间窗: 15-Minutes after Lens Insertion
Absolute rotation was assessed for each subject eye using a slit lamp 15 minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported for each lens.
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees
时间窗: 15-minutes after lens insertion
Rotational Stability was assessed for each subject eye using a slit lamp 15 minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was reported for each lens.
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
时间窗: Up to 1-Week Follow-up
Slit Lamp Findings (SLF) were assessed using a biomicroscope and were graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens.
Proportion of Eyes With Acceptable Lens Fitting
时间窗: Up to 1-Week Follow-up
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens.
次要结局
- Subjective Overall Comfort(At each 1-week follow-up per wear period)
- Subjective Overall Quality of Vision(At each 1-week follow-up per wear period)
- Subjective Overall Handling(At each 1-week follow-up per wear period)
- CLUE Vision Score(1-Week Follow-up)
- CLUE Comfort Score(1-Week Follow-up)
- CLUE Handling Score(1-Week Follow-up)