Characterizing Successful Myopic Multifocal Contact Lens Wearers

Study Overview
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Brief Summary
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This will be a prospective, single group, single-arm, and bilateral dispensing study. Subjects will be assigned to a single study lens type to be worn bilaterally in daily wear, and daily disposable modality, for at least 6 hours per day every day for approximately 12 weeks.

Official Title
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Characterizing Successful Myopic Multifocal Contact Lens Wearers

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: Acuvue Moist Multifocal Contact Lens JJVC Marketed Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential Subjects must satisfy all of the following criteria to be enrolled in the study: The participant must 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. Is at least 40 years of age (inclusive) at the time of screening and has full legal capacity to volunteer. Had a self-reported eye examination in the last two years. The subject must either already be wearing a presbyopic correction (e.g., reading spectacles over contact lenses, or multifocal spectacles, etc.) or respond positively to at least one symptom on the 'Presbyopic Symptoms Questionnaire. Can achieve best corrected distance monocular visual acuity of at least +0.20 logMAR and binocular visual acuity of at least +0.10 logMAR with refraction. Have a refractive cylinder of ≤1.00 D in each eye. Has corrected best sphere equivalent distance refraction in the range -0.50 D of -6.00 D in each eye (vertex corrected if greater than -4.00D). Have a reading ADD power in the range of +0.75 D to +1.75 D (inclusive) in each eye. Have a wearable pair of spectacles (at the discretion of the investigator) to wear when they cannot wear the study lenses. Exclusion Criteria: Potential Subjects who meet any of the following criteria will be excluded from participating in the study: Participation in any contact lens or lens care clinical trial within 1 week prior to study enrollment. Employee or immediate family member of an employee of the Centre for Ocular Research & Education listed on the study Delegation Log (e.g., Investigator, Coordinator, Technician). Is currently pregnant or lactating, by self-report, or planning a pregnancy at the time of enrollment. Has any known active ocular disease and/or allergies, ocular infections or other abnormalities that are known to interfere with contact lens wear (at the discretion of the investigator). This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or corneal distortion. Is using any topical ocular medications other than lubricating eye drops. Known to have any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease. Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the discretion of the investigator). This may include, but not be limited to, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes. Had a diagnosis of a condition known to affect ocular prescription or ocular surface or tear film e.g., rheumatoid arthritis, diabetes. Had a change within the previous 3 months to the dosage of a systemic medication known to affect ocular prescription or ocular surface or tear film (e.g., steroids) that in the opinion of the investigator may affect a study outcome variable. Has undergone cataract or refractive error surgery (e.g., radial keratotomy, PRK, LASIK, etc.), or has any planned (during the study) major surgery (e.g. hip replacement), or any planned ocular surgery (e.g. cataract or refractive error surgery). Is a current rigid contact lens wearer, or is wearing contact lenses on extended wear basis, or has a history of extended wear in the past 6 months. Has worn soft MF CLs in the past 2 years or is a habitual wearer of monovision CLs. Has a constant unilateral strabismus at both far and near distances, or has anisometropia >2 D between both eyes, or has amblyopia. Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study (Refresh Plus® rewetting drop solution, Sodium Fluorescein or Alcon Clear Care Cleaning System). Has any Grade 3.0 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the biomicroscopy classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear (at the discretion of the investigator).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JJVC Marketed Contact Lens<br>Eligible subjects that have no experience with soft multifocal lenses for more than 2 years will be assigned to a single study lens type worn in both eyes daily for at least 6 hours per day, everyday for approximately 12 weeks. | Device: Acuvue Moist Multifocal Contact Lens JJVC Marketed Contact Lens<br>* JJVC Marketed Contact Lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quest Questionnaire Classification Summary | Subjects are classified into 1 of 4 mutually exclusive groups based on their responses to 6 individual items. 5 items were assessed using the 7-point like-rt scale. A composite score Life Satisfaction was calculated for each subject by summing their responses, the final score ranges 0-35 points. Where higher scores indicate higher satisfaction with life. The final item was assessed using a 5 point like-rt scale. If a subject scored 26 or higher for the composite score and responded positively (4 or 5) to the final item, then a subject was classified as Content & Driven. If a subject scored 26 or higher but did not respond positively, then Content & Indifferent. If a subject scored lower than 26 and responded positively, then Discontented & Driven. Lastly, if a subject scored lower than 26 but did not respond positively, then Discontented & Indifferent. The percentage of subjects for each group was reported. | Baseline | 
| Proportion of Successful Lens Wearers | Successful lens wearers were defined as subjects that fit the following criteria: 1.Completed all required study visits, 2. responded Excellent or Very Good to both the individual questionnaire items (Overall quality of vision and Overall Comfort) and 3. the investigator would recommend the study lenses. Overall quality of Vision and Overall Comfort are individual questionnaire items with the response set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Investigator recommendation was determined by the individual item In your opinion, is it suitable to prescribe contact lenses for this subject? (Yes/No). The proportion of successful lens wearers was reported. | 12-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Contrast Threshold | Monocular Contrast threshold was measured at Distance (4 meter) for both the left and right eyes using the M&S clinical trial suit (CTS) under standard room illumination. Contrast threshold was collected at Baseline, post lens fitting, 2-week follow-up evaluation and the 12-week evaluation. Contrast threshold at baseline was measured while wearing a spherical-cylinder refraction in a trial frame. The M&S system displayed the contrast threshold score in log units. The average contrast threshold was reported for each timepoint. | Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up | 
| Binocular Contrast Threshold | Binocular Contrast threshold was measured at Distance (4 meter) using the M&S clinical trial suit (CTS) under standard room illumination. Contrast threshold was collected at Baseline, post lens fitting, 2-week follow-up evaluation and the 12-week evaluation. Contrast threshold at baseline was measured while wearing a spherical-cylinder refraction in a trial frame. The M&S system displayed the contrast threshold score in log units. | Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up | 
| Photopic Pupillometry | Pupillometry was measured for both the left and right eyes at baseline and the 1-week follow-up evaluation . Pupil size was measured at distance, intermediate and near positions under photopic (500 lux) conditions using the NeurOptic VIP-300 pupilometer. The average pupil size across both eyes was reported for each distance and timepoint. | Baseline, 1-Week Follow-up | 
| Scotopic Pupillometry | Pupillometry was measured for both the left and right eyes at baseline and the 1-week follow-up evaluation . Pupil size was measured at distance, intermediate and near positions under scotopic (0 lux) conditions using the NeurOptic VIP-300 pupilometer. The average pupil size across both eyes was reported for each distance and timepoint. | Baseline, 1-Week Follow-up | 
| Near Stereopsis Threshold | Near Stereopsis threshold was collected binocularly using a Randot Stereopsis book at near (40cm) at baseline (over bare eyes), and at 10-minutes post lens fitting, 2-Week and 12-week follow-up evaluations over the study contact lenses. The average stereopsis threshold for each timepoint was reported. | Baseline, 10-mintue Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up | 
| Blur Tolerance | Blur tolerance was assessed by subjects being presented with a series on images on a screen. Two aspects of blur were evaluated, noticeable blur and objectionable blur; where, noticeable blur was defined as the threshold in diopters at which point the subject indicated a just noticeable blur, while objectional blur was defined as the point which the subject indicated the blur of the image to be absolutely intolerable. Blur tolerance was measured binocularly at 1-meter at baseline only. | Baseline | 
| Fixation Disparity With Refraction | Fixation disparity with Refraction was measured at baseline with a Mallet Unit for both distance (4 meter) and near (40 cm). This test measures small misalignments between eyes when the eyes are in a fused state. The average amount of base (prism diopters) was reported. The Amount of base can range from 0.00 to 4.00. | Baseline | 
| Non-invasive Tear Break-up Time | Measurement of non-invasive tear break up time (NITBUT) was conducted using a Placido disc topographer in both the left and right eyes on a bare eye at baseline and over the study contact lens 10 minutes post-lens insertion and at the 2-Week follow-up evaluation. Subjects were instructed to blink three times and then hold their eyes open. At the hold time was started, time was stopped once the first area of distortion or break in the tear film was observed. Three replicates were taken on each eye. The average NITBUT across eyes and replicate at each time point was provided. Larger values of NITBUT indicates better tear film. | Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up | 
| Coma | Coma was measured over 2 seconds after blink in both the left and right eyes at baseline (over bare eye) and at 10-minutes post-lens fitting, 2-week, and 12-week follow-up evaluations over the study contact lenses using the COAS wavefront sensor. Both vertical and horizontal Coma was collected in each eye. The average vertical and horizontal coma at each timepoint was reported. | Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up | 
| Higher Order Aberration | Higher Order Aberration (HOA) was measured over 2 seconds after blink in both the left and right eyes at baseline (over bare eye) and at 10-minutes post-lens fitting, 2-week, and 12-week follow-up evaluations over the study contact lenses using the COAS wavefront sensor. The average HOA at each timepoint was reported. | Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up | 
| Keratometry (Diopters) | Keratometry (corneal curvature) collected at baseline for each eye (left and right) using an autokeratometer. The measurement was recorded in diopters (DK) of major keratometric meridians. The average of each measurement was reported. | Baseline | 
| Keratometry (Degrees) | Keratometry (corneal curvature) collected at baseline for each eye (left and right) using an autokeratometer. The measurement was recorded for locations (degrees) of major keratometric meridians. The average of each measurement was reported. | Baseline | 
| Objective Accommodation With Distance Refraction | Objective accommodation with sphero-cylindrical distance refraction was collected using the WAM-5500 auto-refractor at distance (4-meter), Intermediate (1-meter) and Near (40cm) in both the left and right eyes at baseline, 10-minutes post lens fitting, 2-week and 12-week follow-up evaluations. Measurements at baseline were collected on bare eyes and over the study contact lens at the follow-up evaluations. The average sphere power (diopters) across eyes was report for each distance and timepoint. | Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up | 
| Binocular Visual Acuity (logMAR) | Binocular Visual Acuity (logMAR) was collected using logMAR visual acuity chart under standard room illumination at distance (4 meter), intermediate (64cm) and near (40cm) at 10 minutes-post lens fitting, and the 1-, 2-, 6- and 12-week follow-up evaluations. However, intermediate was not collected post fitting and at the 1-week follow-up evaluation. A value of 0.0 logMAR is approximate to 20/20 Snellen Visual Acuity. Lower values of visual acuity (logMAR) indicate better vision. The average visual acuity was reported for each distance and timepoint. | 10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-up | 
| Monocular Visual Acuity (logMAR) | Monocular Visual Acuity (logMAR) was collected in both the left and right eyes using logMAR visual acuity chart under standard room illumination at distance (4 meter), intermediate (64cm) and near (40cm) at 10 minutes-post lens fitting, and the 1-, 2-, 6- and 12-week follow-up evaluations. However, intermediate was not collected post fitting and at the 1-week follow-up evaluation. A value of 0.0 logMAR is approximate to 20/20 Snellen Visual Acuity. Lower values of visual acuity (logMAR) indicate better vision. The average visual acuity was reported for each distance and timepoint. | 10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-up |