Design Validation of Senofilcon A With New UV-blocking Ad... | NCT03707821

Label	Type	Description	Intervention Names
senofilcon A TEST Lens	Experimental	Subjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the TEST Lens for the duration of the clinical study.	Device: senofilcon A TEST Lens
senofilcon A CONTROL Lens	Active Comparator	Subjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the CONTROL Lens for the duration of the clinical study.	Device: senofilcon A CONTROL Lens

Name	Type	Description	Arm Group Labels	Other Names
senofilcon A TEST Lens	Device	JJVC Investigational Contact Lens	senofilcon A TEST Lens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Comfort Score	Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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.	2-Week Follow-up Evlauation
Vision Satisfaction in Bright Lighting	Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ 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 Proportion of responses in each category were reported for each lens type.	2-Week Follow-up Evaluation
Distance Visual Acuity	Distance visual acuity was assessed by eye using LogMAR visual acuity at 4 meters using an ETDRS chart under high illumination high contrast conditions (room illumination > 400 lux and chart luminance 120-200 cd/m2) at the 2-week follow-up for each subject eye. Lower values of logMAR indicate better vision, where a score of 0.0 equates to 20/20 snellen vision. The average visual acuity for each lens was reported.	2-Week Follow-up Evlauation
Contact Lens Fitting Acceptance Rate

Secondary Outcomes

Measure	Description	Time Frame
Overall Handling Score	Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. The subject 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. Between 18 and 49 (inclusive) years of age at the time of informed consent.
4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them when needed for near vision.
5. The subject is a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
7. Subjects must own a wearable pair of distance spectacles.
8. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
9. The subject's refractive cylinder must be 0.00 to -1.00 D (inclusive) in each eye.
10. The subject must have a spherocylindrical best corrected distance Snellen visual acuity of 20/25+3 or better in each eye.
  
  Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis).
3. Subjects taking suspect oral medications for less than one year.
4. Any prescribed or over the counter (OTC) ocular medication.
5. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
6. Toric, extended wear, monovision or multi-focal contact lens correction.
7. Any previous or planned (during the course of the study) ocular surgery (e.g., PRK, LASIK, etc.).
8. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
9. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
11. Binocular vision abnormality or strabismus by self-report or prior medical history.
12. History of recurrent corneal erosions, herpetic keratitis, or pathological dry eye.
13. Any active ocular allergies, infections or other ocular abnormalities (entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma) that the investigator determines may interfere with the outcomes of this study or otherwise contraindicate participation in the study.
14. Any Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale.
15. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar) within the past 3 years of otherwise successful contact lens wear.

Facility	Status	City	State	ZIP	Country	Contacts
James T. Fujimoto, OD		Cupertino	California	95014	United States
Maitland Vision Center

ID	Title	Description
FG000	Test	Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
FG001	Control	Subjects that wore the Control lens in both eyes throughout the entire duration of the study.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Nov 18, 2018	Oct 22, 2019

ID	Title	Description
BG000	Test	Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
BG001	Control	All subjects dispensed the Control lens in both eyes throughout the entire duration of the study.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000125 BG001126 BG002251

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

Overall Comfort Score

Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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 subjects that completed the study without a major protocol deviation impacting a primary endpoint.

Posted

Mean

Standard Deviation

Units on a Scale

2-Week Follow-up Evlauation

ID	Title	Description
OG000	Test	Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
OG001	Control	Subjects that wore the Control lens in both eyes during the entire duraiton of the study.

Units	Counts
Participants	OG000122 OG001124

Title

Denominators

Categories

Title	Measurements
	OG00064.7± 21.33 OG00162.6± 23.38

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 OG001	It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 5 points difference in mean overall comfort at he 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).	Bayesian normal random-effects	A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.			Mean Difference (Net)	3.3	Standard Deviation	2.65	2-Sided	95	-2.0	8.5			Mean difference was calculated as Test minus Control.

Primary

Vision Satisfaction in Bright Lighting

Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ 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 Proportion of responses in each category were reported for each lens type.

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

Posted

Number

Percentage of subjects

2-Week Follow-up Evaluation

ID	Title	Description
OG000	Test	Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
OG001	Control	Subjects that wore the Control lens in both eyes during the entire duraiton of the study.

Primary

Distance Visual Acuity

Distance visual acuity was assessed by eye using LogMAR visual acuity at 4 meters using an ETDRS chart under high illumination high contrast conditions (room illumination > 400 lux and chart luminance 120-200 cd/m2) at the 2-week follow-up for each subject eye. Lower values of logMAR indicate better vision, where a score of 0.0 equates to 20/20 snellen vision. The average visual acuity for each lens was reported.

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

Posted

Mean

Standard Deviation

logMAR

2-Week Follow-up Evlauation

eyes

ID	Title	Description
OG000	Test	Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
OG001	Control	Subjects that wore the Control lens in both eyes during the entire duraiton of the study.

Units	Counts
Participants	OG000

Primary

Contact Lens Fitting Acceptance Rate

Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Fit acceptance rate will be based on the lens fit acceptance of eyes wearing the Test lens only. Fit acceptance is a binary response where Y=1 if lens fit is acceptable and Y=0 otherwise. Unacceptable is defined as unacceptable if any one of the following criteria:

limbal exposure at primary gaze or with extreme eye movement;
edge lift;
excessive movement in primary up gaze;
insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.

Eyes with multiple unacceptable fitting events will be counted only once. Fit rates of the Control lens will also be collected but are not a primary endpoint.

All subjects that were dispsensed a study lens.

Posted

Number

Percentage of eyes

Up to 2-Week Follow-up

eyes

ID	Title	Description
OG000	Test	Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
OG001	Control	Subjects that wore the Control lens in both eyes during the entire duraiton of the study.

Units	Counts

Primary

Number of 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). Slit Lamp Findings will be assessed for each subject eye at all study visits (schedule and unscheduled). SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The percentage of eyes with Grade 3 or higher slit lamp findings will be analyzed and will include corneal infiltrates. Eyes with multiple events will be counted only once. The number of eyes with SLF with grade 3 or higher by lens was reported.

All subjects that were dispensed a study lens.

Posted

Number

Number of eyes

Up to 2-Week Follow-up Evlauation

eyes

ID	Title	Description
OG000	Test	Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
OG001	Control	Subjects that wore the Control lens in both eyes during the entire duraiton of the study.

Units	Counts

Secondary

Overall Handling Score

Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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 subjects that completed the study without a major protocol deviation impacting a primary endpoint.

Posted

Mean

Standard Deviation

Units on a Scale

2-Week Follow-up Evlauation

ID	Title	Description
OG000	Test	Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
OG001	Control	Subjects that wore the Control lens in both eyes during the entire duraiton of the study.

Units	Counts
Participants

Secondary

Overall Quality of Vision Score

Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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 subjects that completed the study without a major protocol deviation impacting a primary endpoint.

Posted

Mean

Standard Deviation

Units on a Scale

2-Week Follow-up Evlauation

ID	Title	Description
OG000	Test	Subjects that wore the Test lens in both eyes during the entire duraiton of the study.
OG001	Control	Subjects that wore the Control lens in both eyes during the entire duraiton 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	Subjects that wore the Test lens in both eyes during the entire duraiton of the study.	0	125	0	125	0	125
EG001	Control	Subjects that wore the Control lens at any point during the study.	0	126	0	126	0	126