Characterizing Successful Myopic Multifocal Contact Lens Wearers

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04178772
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arm: 1
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: Acuvue Moist Multifocal Contact Lens JJVC Marketed Contact Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Characterizing Successful Myopic Multifocal Contact Lens Wearers
• Actual Study Start Date: Nov 4, 2019
• Actual Primary Completion Date: Jan 19, 2021
• Actual Study Completion Date: Jan 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JJVC Marketed Contact Lens 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; JJVC Marketed Contact Lens

Outcome Measures

Primary Outcome Measures

1. Quest Questionnaire Classification Summary [Baseline]

   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.

2. Proportion of Successful Lens Wearers [12-Week Follow-up]

   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.

Secondary Outcome Measures

1. Monocular Contrast Threshold [Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up]

   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.

2. Binocular Contrast Threshold [Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up]

   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.

3. Photopic Pupillometry [Baseline, 1-Week Follow-up]

   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.

4. Scotopic Pupillometry [Baseline, 1-Week Follow-up]

   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.

5. Near Stereopsis Threshold [Baseline, 10-mintue Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up]

   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.

6. Blur Tolerance [Baseline]

   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.

7. Fixation Disparity With Refraction [Baseline]

   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.

8. Non-invasive Tear Break-up Time [Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up]

   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.

9. Coma [Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up]

   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.

10. Higher Order Aberration [Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up]

    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.

11. Keratometry (Diopters) [Baseline]

    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.

12. Keratometry (Degrees) [Baseline]

    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.

13. Objective Accommodation With Distance Refraction [Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up]

    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.

14. Binocular Visual Acuity (logMAR) [10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-up]

    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.

15. Monocular Visual Acuity (logMAR) [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) 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Potential Subjects must satisfy all of the following criteria to be enrolled in the study:

1. The participant must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. Is at least 40 years of age (inclusive) at the time of screening and has full legal capacity to volunteer.

4. Had a self-reported eye examination in the last two years.

5. 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".

6. 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.

7. Have a refractive cylinder of ≤1.00 D in each eye.

8. 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).

9. Have a reading ADD power in the range of +0.75 D to +1.75 D (inclusive) in each eye.

10. 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:

1. Participation in any contact lens or lens care clinical trial within 1 week prior to study enrollment.

2. 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).

3. Is currently pregnant or lactating, by self-report, or planning a pregnancy at the time of enrollment.

4. 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.

5. Is using any topical ocular medications other than lubricating eye drops.

6. Known to have any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.

7. 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.

8. Had a diagnosis of a condition known to affect ocular prescription or ocular surface or tear film e.g., rheumatoid arthritis, diabetes.

9. 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.

10. 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).

11. 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.

12. Has worn soft MF CLs in the past 2 years or is a habitual wearer of monovision CLs.

13. Has a constant unilateral strabismus at both far and near distances, or has anisometropia >2 D between both eyes, or has amblyopia.

14. 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).

15. 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Ocular Research and Education, University of Waterloo	Waterloo	Ontario	Canada

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

• Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 20, 2019

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT04178772
• Other Study ID Numbers: CR-5945
• First Posted: Nov 26, 2019
• Last Update Posted: Mar 23, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

Participant Flow

Recruitment Details	A total of 29 subjects were enrolled into this study. Of those enrolled, 27 were dispensed study lenses, while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 19 completed the study while 8 subjects were discontinued. This study was terminated early due to COVID-19.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Period Title: Overall Study
STARTED	27
COMPLETED	19
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Dispensed Subject
Arm/Group Description	All subjects dispensed a study lens.
Overall Participants	27
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.8 (3.95)
Sex: Female, Male (Count of Participants)
Female	22 81.5%
Male	5 18.5%
Race/Ethnicity, Customized (participants) [Number]
Black or African American	2 7.4%
White	24 88.9%
Other	1 3.7%
Region of Enrollment (Count of Participants)
Canada	27 100%

Outcome Measures

1. Primary Outcome

Title	Quest Questionnaire Classification Summary
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Discontented & Driven	22.2 82.2%
Content & Driven	33.3 123.3%
Discontented & Indifferent	11.2 41.5%
Content & Indifferent	33.3 123.3%

2. Primary Outcome

Title	Proportion of Successful Lens Wearers
Description	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.
Time Frame	12-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Number [Proportion of Participants]	0.593 2.2%

3. Secondary Outcome

Title	Monocular Contrast Threshold
Description	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.
Time Frame	Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Measure eyes	54
Baseline	-1.32 (0.174)
Post Lens Fitting	-1.15 (0.244)
2-Week Follow-up	-1.24 (0.196)
12-Week Follow-up	-1.16 (0.226)

4. Secondary Outcome

Title	Binocular Contrast Threshold
Description	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.
Time Frame	Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Baseline	-1.46 (0.178)
Post Lens Fitting	-1.32 (0.228)
2-Week Follow-up	-1.43 (0.196)
12-Week Follow-up	-1.35 (0.209)

5. Secondary Outcome

Title	Photopic Pupillometry
Description	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.
Time Frame	Baseline, 1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Baseline: Distance (4 meter)	3.85 (0.578)
Baseline: Intermediate (1 meter)	3.73 (0.568)
Baseline: Near (40 cm)	3.70 (0.608)
1-Week Follow-up: Distance (4 meter)	3.87 (0.502)
1-Week Follow-up: Intermediate (1 meter)	3.64 (0.428)
1-Week Follow-up: Near (40 cm)	3.44 (0.463)

6. Secondary Outcome

Title	Scotopic Pupillometry
Description	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.
Time Frame	Baseline, 1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Baseline: Distance (4 meter)	5.92 (0.804)
Baseline: Intermediate (1 meter)	5.75 (0.786)
Baseline: Near (40 cm)	5.33 (0.816)
1-Week Follow-up: Distance (4 meter)	5.79 (0.872)
1-Week Follow-up: Intermediate (1 meter)	5.65 (0.769)
1-Week Follow-up: Near (40 cm)	5.19 (0.839)

7. Secondary Outcome

Title	Near Stereopsis Threshold
Description	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.
Time Frame	Baseline, 10-mintue Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects enrolled the study.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	28
Baseline	43.04 (17.968)
10-minutes Post Lens Fitting	58.54 (51.213)
2-Week Follow-up	43.48 (16.544)
12-Week Follow-up	41.67 (14.577)

8. Secondary Outcome

Title	Blur Tolerance
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Noticeable blur	0.2 (0.06)
Objectionable blur	0.3 (0.07)

9. Secondary Outcome

Title	Fixation Disparity With Refraction
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Distance	0.74 (1.130)
Near	0.63 (1.079)

10. Secondary Outcome

Title	Non-invasive Tear Break-up Time
Description	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.
Time Frame	Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Measure eyes	54
Baseline	5.99 (3.839)
10 minutes Post-Lens Insertion	3.75 (1.241)
2-Week Follow-up	3.88 (1.667)

11. Secondary Outcome

Title	Coma
Description	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.
Time Frame	Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Measure eyes	54
Horizontal: Baseline	0.02 (0.045)
Horizontal: 10 minutes Post-Lens Insertion	0.03 (0.062)
Horizontal: 2-Week Follow-up	0.03 (0.066)
Horizontal: 12-Week Follow-up	0.03 (0.076)
Vertical: Baseline	0.02 (0.047)
Vertical: 10 minutes Post-Lens Insertion	0.03 (0.054)
Vertical: 2-Week Follow-up	0.02 (0.054)
Vertical: 12-Week Follow-up	0.01 (0.080)

12. Secondary Outcome

Title	Higher Order Aberration
Description	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.
Time Frame	Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Measure eyes	54
Baseline	0.17 (0.044)
10 minutes Post-Lens Insertion	0.21 (0.146)
2-Week Follow-up	0.23 (0.207)
12-Week Follow-up	0.21 (0.060)

13. Secondary Outcome

Title	Keratometry (Diopters)
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Measure eyes	54
Steep	44.46 (1.628)
Flat	43.72 (1.735)

14. Secondary Outcome

Title	Keratometry (Degrees)
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Measure eyes	54
Steep	86.43 (21.576)
Flat	106.43 (74.425)

15. Secondary Outcome

Title	Objective Accommodation With Distance Refraction
Description	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.
Time Frame	Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Measure eyes	54
Distance: Baseline	0.61 (0.400)
Distance: 10-Minutes Post Lens Fitting	0.17 (0.347)
Distance: 2-Week Follow-up	0.15 (0.296)
Distance: 12-Week Follow-up	0.11 (0.296)
Intermediate: Baseline	0.35 (0.450)
Intermediate: 10-Minutes Post Lens Fitting	-0.09 (0.343)
Intermediate: 2-Week Follow-up	-0.06 (0.366)
Intermediate: 12-Week Follow-up	-0.11 (0.335)
Near: Baseline	-0.24 (0.684)
Near: 10-Minutes Post Lens Fitting	-0.57 (0.509)
Near: 2-Week Follow-up	-0.60 (0.596)
Near: 12-Week Follow-up	-0.61 (0.407)

16. Secondary Outcome

Title	Binocular Visual Acuity (logMAR)
Description	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.
Time Frame	10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Distance: 10-Minutes Post Lens Fitting	-0.076 (0.0719)
Distance: 1-Week Follow-up	-0.104 (0.0646)
Distance: 2-Week Follow-up	-0.102 (0.0741)
Distance: 6-Week Follow-up	-0.107 (0.0681)
Distance: 12-Week Follow-up	-0.098 (0.0570)
Near: 10-Minutes Post Lens Fitting	-0.012 (0.1013)
Near: 1-Week Follow-up	-0.024 (0.1091)
Near: 2-Week Follow-up	-0.051 (0.1019)
Near: 6-Week Follow-up	-0.077 (0.0922)
Near: 12-Week Follow-up	-0.027 (0.1196)
Intermediate: 2-Week Follow-up	-0.152 (0.0725)
Intermediate: 6-Week Follow-up	-0.166 (0.0476)
Intermediate: 12-Week Follow-up	-0.131 (0.0549)

17. Secondary Outcome

Title	Monocular Visual Acuity (logMAR)
Description	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.
Time Frame	10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
Measure Participants	27
Measure eyes	54
Distance: 10-Minutes Post Lens Fitting	-0.013 (0.0828)
Distance: 1-Week Follow-up	-0.034 (0.0808)
Distance: 2-Week Follow-up	-0.038 (0.0774)
Distance: 6-Week Follow-up	-0.040 (0.0790)
Distance: 12-Week Follow-up	-0.024 (0.0708)
Near: 10-Minutes Post Lens Fitting	0.082 (0.1060)
Near: 1-Week Follow-up	0.063 (0.1185)
Near: 2-Week Follow-up	0.019 (0.0975)
Near: 6-Week Follow-up	0.021 (0.0899)
Near: 12-Week Follow-up	0.029 (0.1039)
Intermediate: 2-Week Follow-up	-0.074 (0.0826)
Intermediate: 6-Week Follow-up	-0.095 (0.0657)
Intermediate: 12-Week Follow-up	-0.064 (0.0721)

Adverse Events

Time Frame	Throughout the entire duration of the study. Approximately 3 months per subject.
Arm/Group Title	Etafilcon A Multifocal Lens
Arm/Group Description	Subjects that wore the etafilcon A lens during any point of the study.
All Cause Mortality
	Etafilcon A Multifocal Lens
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Serious Adverse Events
	Etafilcon A Multifocal Lens
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A Multifocal Lens
	Affected / at Risk (%)	# Events
Total	0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.