Design Validation of Toric Contact Lenses in Senofilcon A... | NCT05778786

Label	Type	Description	Intervention Names
Test/Control	Experimental	Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (test then control) with a washout period of 7+/-2 days duration between wear periods.	Device: Acuvue Oasys 1 Day for Astigmatism Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore
Control/Test	Experimental	Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (control then test) with a washout period of 7+/-2 days duration between wear periods.	Device: Acuvue Oasys 1 Day for Astigmatism Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore

Name	Type	Description	Arm Group Labels	Other Names
Acuvue Oasys 1 Day for Astigmatism	Device	CONTROL	Control/Test Test/Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Distance Monocular logMAR Visual Acuity	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 a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.	1-Week Follow-up
CLUE Vision Score	Subjective vision was 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.	1-Week Follow-up
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees	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 report for each lens.	15-minutes after lens insertion
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees	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 report for each lens.

Secondary Outcomes

Measure	Description	Time Frame
CLUE Comfort Score	Subjective comfort was 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 comfort score was reported.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

The subject 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.
Be between 18 and 39 years of age (inclusive) at the time of screening.
Habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.
Possess a wearable pair of spectacles that provide correction for distance vision.
In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:
1. Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
2. Cylinder powers (DC) -0.75 and -1.25
3. Axes (°) 170, 180, 10, 80, 90, 100
Have best corrected monocular distance visual acuity of 20/30 or better in each eye.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

The subject must not:

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, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Name	Affiliation	Role
Johnson & Johnson Vision Care, Inc. Clinical Trial	Johnson & Johnson Vision Care, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stam & Associates Eye Care		Jacksonville	Florida	32256	United States
Omega Vision Center

ID	Title	Description
FG000	Test-senofilcon A (C3)/Control-senofilcon A (C3)	Subjects in this arm were randomized to receive the Test lens during the first period of the study and the Control lens during the second period of the study.
FG001	Control-senofilcon A (C3)/ Test-senofilcon A (C3)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 1, 2023

ID	Title	Description
BG000	Dispensed Subjects	All subjects dispensed at least one study lens.

Units	Counts
Participants	BG000188

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

Distance Monocular logMAR Visual Acuity

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 a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.

Posted

Mean

Standard Deviation

logMAR

1-Week Follow-up

Eyes

ID	Title	Description
OG000	Test-senofilcon A (C3)	Subjects that wore the Test lens during either period 1 or period 2 of the study
OG001	Control-senofilcon A (C3)	Subjects that wore the Control lens during either period 1 or period 2 of the study

Units	Counts
Participants	OG000180 OG001181
Eyes	OG000360 OG001

Title

Denominators

Categories

Title	Measurements
	OG000-0.107± 0.0740 OG001-0.104± 0.0705

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 using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 9 subjects provide at least 99% statistical power to test for superiority.	Linear Mixed Model				Least-Square Mean	-0.13	Standard Error of the Mean	0.012	1-Sided	95		-0.10					Superiority	A superiority margin of 0.0 logMAR was used.

Primary

CLUE Vision Score

Subjective vision was 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.

All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.

Posted

Mean

Standard Deviation

Units on a scale

1-Week Follow-up

ID	Title	Description
OG000	Test-senofilcon A (C3)	Subjects that wore the Test lens during either period 1 or period 2 of the study
OG001	Control-senofilcon A (C3)	Subjects that wore the Control lens during either period 1 or period 2 of the study

Units	Counts
Participants

Primary

Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees

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 report for each lens.

All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.

Posted

Number

Proportion of eyes

15-minutes after lens insertion

Eyes

ID	Title	Description
OG000	Test-senofilcon A (C3)	Subjects that wore the Test lens during either period 1 or period 2 of the study
OG001	Control-senofilcon A (C3)	Subjects that wore the Control lens during either period 1 or period 2 of the study

Units	Counts
Participants

Primary

Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees

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 report for each lens.

All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.

Posted

Number

Proportion of eyes

15-minutes after lens insertion

Eyes

ID	Title	Description
OG000	Test-senofilcon A (C3)	Subjects that wore the Test lens during either period 1 or period 2 of the study
OG001	Control-senofilcon A (C3)	Subjects that wore the Control lens during either period 1 or period 2 of the study

Units	Counts
Participants

Primary

Proportion of Eyes With Acceptable Lens Fitting

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.

All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.

Posted

Number

Proportion of eyes

Up to 1-Week Follow-up

Eyes

ID	Title	Description
OG000	Test-senofilcon A (C3)	Subjects that wore the Test lens during either period 1 or period 2 of the study
OG001	Control-senofilcon A (C3)	Subjects that wore the Control lens during either period 1 or period 2 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 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.

All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.

Posted

Number

Proportion of eyes

Up to 1-Week Follow-up

Eyes

ID	Title	Description
OG000	Test-senofilcon A (C3)	Subjects that wore the Test lens during either period 1 or period 2 of the study
OG001	Control-senofilcon A (C3)	Subjects that wore the Control lens during either period 1 or period 2 of the study

Units	Counts
Participants

Secondary

CLUE Comfort Score

Subjective comfort was 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 comfort score was reported.

All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.

Posted

Mean

Standard Deviation

Units on a scale

1-Week Follow-up

ID	Title	Description
OG000	Test-senofilcon A (C3)	Subjects that wore the Test lens during either period 1 or period 2 of the study
OG001	Control-senofilcon A (C3)	Subjects that wore the Control lens during either period 1 or period 2 of the study

Units	Counts
Participants

Secondary

CLUE Handling Score

Subjective handling was 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 handling score was reported.

All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.

Posted

Mean

Standard Deviation

Units on a scale

1-Week Follow-up

ID	Title	Description
OG000	Test-senofilcon A (C3)	Subjects that wore the Test lens during either period 1 or period 2 of the study
OG001	Control-senofilcon A (C3)	Subjects that wore the Control lens during either period 1 or period 2 of the study

Units	Counts
Participants

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Test-senofilcon A (C3)	Subjects that wore the Test lens during any point of the study.	0	185	0	185	0	185
EG001	Control-senofilcon A (C3)	Subjects that wore the Control lens during any point of the study.	0	184	0	184	0	184