Clinical Evaluation of a Daily Wear Reusable Multifocal O... | NCT04534517

Label	Type	Description	Intervention Names
TEST Lens	Experimental	Eligible subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age will be recruited. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.	Device: JJV Investigational Multifocal Contact Lens Device: ACUVUE OASYS® with HYDRACLEAR® PLUS

Name	Type	Description	Arm Group Labels	Other Names
JJV Investigational Multifocal Contact Lens	Device	TEST Lens	TEST Lens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vision Scores	Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.	2-Week Follow-up
Visual Performance LogMAR	Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4m), intermediate (64cm) and near (40cm) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 to 7.9 EV (394-597 lux). For Distance (4m), the acceptable range for the chart luminance was 10.5-10.7 EV (181 208 cd/m2). For Intermediate (64cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. A logMAR score closer to zero, or below zero, indicates a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar.	2-Week Follow-up
Proportion of Eyes With Unacceptable Lens Fitting	Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristerics are similar for these two populations.	Up to 2-Week Follow-up

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Eyes That Achieved Optimal Lens Pair in 4 Lenses or Less	The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 12. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satisfactory vision with the lenses a modification was not required. However, based upon the investigator's findings on the measured visual acuity and/or over-refraction a modification may have been performed. Data for the hyperope and myope groups were combined for this endpoint since the number of lenses needed to optimize vision is indpendent of which group a subject belongs to.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.
Subjects must own a wearable pair of spectacles if required for their distance vision.
The subject must be an adapted soft contact lens wearer in both eyes (i.e. wears lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month of more duration).
The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" (Appendix E).
The subject's distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) must be in the range of -1.25 D to -5.75 D or +0.75 D to +3.25 D in each eye.
The subject's refractive cylinder must be ≤0.75 D in each eye.
The subject's ADD power must be in the range of +0.75 D to +2.50 D.
The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria:

Currently pregnant or lactating.
Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).
A history of amblyopia, strabismus or binocular vision abnormality.
History of glaucoma, macular degeneration, recurrent corneal erosions, recurrent styes, herpetic keratitis, irregular cornea or pathological dry eye.
Use of any of the following medications within 1 week prior to enrollment: oral retinoids, oral tetracyclines, oral phenothiazines, anticholinergics, corticosteroids.
Use of any ocular medication, with the exception of rewetting drops.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
Any known hypersensitivity or allergic reaction to Optifree® Replenish® multipurpose care solution, sodium fluorescein or non-preserved rewetting drop solutions.
Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
Any current ocular infection or inflammation.
Any current ocular abnormality that may interfere with contact lens wear.

Facility	Status	City	State	ZIP	Country	Contacts
Dr. James Weber & Associates, PA		Jacksonville	Florida	32205	United States
Sabal Eye Care

ID	Title	Description
FG000	Senofilcon A (Investigational Multifocal Lens)	All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 6, 2020	Dec 15, 2021

ID	Title	Description
BG000	Hyperopes	All subjects dispensed a study lens.
BG001	Myopes	All subjects dispensed a study lens.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00055 BG00159 BG002114

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Vision Scores

Overall vision scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.

All subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.

Posted

Mean

Standard Deviation

CLUE points

2-Week Follow-up

ID	Title	Description
OG000	Senofilcon A (Investigational Multifocal Lens)	All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.

Units	Counts
Participants	OG000105

Title

Denominators

Categories

Hyperopes

- ParticipantsOG00050

Title	Measurements
	OG00057.48± 21.175

Myopes

- ParticipantsOG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	It was calculated that 60 participants would have > 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence	Bayesian multivariate random-effects				Mean Estimate	58.6	Standard Deviation	3.26	2-Sided	95	52.3	64.9			Included Hyperope group only		Superiority	The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points

Primary

Visual Performance LogMAR

Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4m), intermediate (64cm) and near (40cm) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 to 7.9 EV (394-597 lux). For Distance (4m), the acceptable range for the chart luminance was 10.5-10.7 EV (181 208 cd/m2). For Intermediate (64cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. A logMAR score closer to zero, or below zero, indicates a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar.

All subjects that completed all study visits without a major protocol deviation impacting a primary endpoint. Hyperopes and myopes were combined based on historical data for subjects in this study with regard to visual performance logMAR.

Posted

Mean

Standard Deviation

logMAR

2-Week Follow-up

ID	Title	Description
OG000	Senofilcon A (Investigational Multifocal Lens)	All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.

Primary

Proportion of Eyes With Unacceptable Lens Fitting

Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristerics are similar for these two populations.

All subjects were dispensed at least one study lens.

Posted

Number

proportion of eyes

Up to 2-Week Follow-up

Eyes

ID	Title	Description
OG000	Senofilcon A (Investigational Multifocal Lens)	All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.

Units	Counts
Participants	OG000

Primary

Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings

Slit Lamp Findings (SLF) were assessed using a biomicroscope and was 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 2-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. Data from the hyperope and myopes group were combined for this outcome since the rate of SLFs grade 3 + is similar for both populations.

All subjects were dispensed at least one study lens.

Posted

Number

proportion of eyes

Up to 2-Week Follow-up

Eyes

ID	Title	Description
OG000	Senofilcon A (Investigational Multifocal Lens)	All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.

Units	Counts
Participants	OG000

Secondary

Proportion of Eyes That Achieved Optimal Lens Pair in 4 Lenses or Less

The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 12. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satisfactory vision with the lenses a modification was not required. However, based upon the investigator's findings on the measured visual acuity and/or over-refraction a modification may have been performed. Data for the hyperope and myope groups were combined for this endpoint since the number of lenses needed to optimize vision is indpendent of which group a subject belongs to.

All subjects were dispensed at least one study lens.

Posted

Number

proportion of eyes

Up to 2-Week Follow-up

Eyes

ID	Title	Description
OG000	Senofilcon A (Investigational Multifocal Lens)	All subjects that wore the investigational multifocal lens made from senofilcon A material during the entire duration of the study.

Units	Counts