Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04794751
• Collaborator: (none)
• Enrollment: 78
• Locations: 7
• Arms: 2
• Actual Duration (Months): 2.9
• Patients Per Site: 11.1
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

This is a single-masked, 2×3 crossover, randomized, dispensing clinical trial to evaluate the visual performance and subjective responses of the JJVC Investigational Contact Lens.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: JJVC Investigational Multifocal Contact Lens; Device: Dailies Total 1® Multifocal Contact Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes
• Actual Study Start Date: Mar 13, 2021
• Actual Primary Completion Date: Jun 10, 2021
• Actual Study Completion Date: Jun 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: senofilcon A C3/delefilcon A/delefilcon A Subjects randomized to this arm will wear the senofilcon A C3 lens during period 1 and the delefilcon A lens during period 2 and period 3	Device: JJVC Investigational Multifocal Contact Lens; senofilcon A C3; Other Names: Test ; Device: Dailies Total 1® Multifocal Contact Lens; delefilcon A; Other Names: Control
Experimental: delefilcon A /senofilcon A C3/senofilcon A C3 Subjects randomized to this arm will wear the delefilcon A lens during period 1 and the senofilcon A C3 lens during period 2 and period 3	Device: JJVC Investigational Multifocal Contact Lens; senofilcon A C3; Other Names: Test ; Device: Dailies Total 1® Multifocal Contact Lens; delefilcon A; Other Names: Control

Outcome Measures

Primary Outcome Measures

1. Visual Performance (logMAR) [1-Week Follow-up]

   Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 m), intermediate (64 cm) and near (40 cm) under high luminance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For Distance (4 m), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64cm) and Near (40cm), the cceptable 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. 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. The average score was reported for each lens.

Secondary Outcome Measures

1. CLUE Vision [1-Week Follow-up]

   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. The average CLUE vision score for each lens type was reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Potential subjects must satisfy all 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. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.

4. Subjects must own a wearable pair of spectacles if required for their distance vision.

5. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).

6. 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).

7. The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D in each eye.

8. The subject's refractive cylinder must be ≤0.75 D in each eye.

9. The subject's ADD power must be in the range of +0.75 D to +2.50 D.

10. The subject must have distance best corrected visual acuity of 20/20-3 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.

2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.

3. 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).

4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).

5. A history of amblyopia, strabismus or binocular vision abnormality.

6. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See Table 9.1 for further examples.

7. Use of any ocular medication, with the exception of rewetting drops.

8. History of herpetic keratitis.

9. History of irregular cornea.

10. History of pathological dry eye.

11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

13. Any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.

14. Clinically significant (Grade 3 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.

15. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions.

16. Any current ocular infection or inflammation.

17. Any current ocular abnormality that may interfere with contact lens wear.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VRC-East	Jacksonville	Florida	United States	32256
2	St. Johns Eye Associates, PA	Saint Augustine	Florida	United States	32092
3	Advanced Eyecare	Raytown	Missouri	United States	64133
4	Spectrum Eyecare	Jamestown	New York	United States	14701
5	Sacco Eye Group	Vestal	New York	United States	13850
6	ProCare Vision Centers	Granville	Ohio	United States	43023
7	Tyler Eye Associates	Tyler	Texas	United States	75703

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 - Feb 10, 2021

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT04794751
• Other Study ID Numbers: CR-6418
• First Posted: Mar 12, 2021
• Last Update Posted: Jun 21, 2022
• Last Verified: May 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	In total, 78 subject were enrolled in this study. Of those enrolled, 75 subjects were dispensed at least one study lens while 3 subjects failed to meet all eligibility criteria. Of those who were assigned and administered a test article, 64 subjects completed the study while 11 subjects were discontinued.

Arm/Group Title	Delefilcon A/Senofilcon A C3/Senofilcon A C3	Senofilcon A C3/Delefilcon A/Delefilcon A
Arm/Group Description	Subjects randomized to this sequence received the delefilcon A lens during the first period and then received the senofilcon A C3 lenses during the second and third periods.	Subjects randomized to this sequence received the senofilcon A C3 lens during the first period and then received the delefilcon A lenses during the second and third periods.
Period Title: Period 1
STARTED	38	37
COMPLETED	36	32
NOT COMPLETED	2	5
Period Title: Period 1
STARTED	36	32
COMPLETED	35	29
NOT COMPLETED	1	3
Period Title: Period 1
STARTED	35	29
COMPLETED	35	29
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dispensed Subjects
Arm/Group Description	All subjects dispensed a study lens.
Overall Participants	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.5 (6.44)
Sex: Female, Male (Count of Participants)
Female	60 80%
Male	15 20%
Race/Ethnicity, Customized (participants) [Number]
Black or African American	4 5.3%
Native Hawaiian or Other Pacific Islander	2 2.7%
White	69 92%
Region of Enrollment (Count of Participants)
United States	75 100%

Outcome Measures

1. Primary Outcome

Title	Visual Performance (logMAR)
Description	Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 m), intermediate (64 cm) and near (40 cm) under high luminance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For Distance (4 m), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64cm) and Near (40cm), the cceptable 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. 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. The average score was reported for each lens.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Senofilcon A C3	Delefilcon A
Arm/Group Description	Subjects that wore the Test lens in either of the three study periods.	Subjects that wore the Control lens in either of the three study periods.
Measure Participants	64	64
Distance (4m)	-0.08 (0.068)	-0.06 (0.081)
Intermediate (64cm)	-0.01 (0.096)	0.00 (0.090)
Near (40cm)	0.10 (0.094)	0.09 (0.089)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A C3, Delefilcon A
	Comments	Distance (4m)
	Type of Statistical Test	Non-Inferiority
	Comments	Non-Inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	least-square mean difference
	Estimated Value	-0.018
	Confidence Interval	(2-Sided) 95%; -0.039 to 0.002
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0106
	Estimation Comments	LS Mean difference was calculated as Test minus Control

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A C3, Delefilcon A
	Comments	Intermediate (64cm)
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	least-square mean difference
	Estimated Value	-0.007
	Confidence Interval	(2-Sided) 95%; -0.032 to 0.018
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0127
	Estimation Comments	LS Mean difference was calculated as Test minus Control

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A C3, Delefilcon A
	Comments	Near (40cm)
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	least-square mean difference
	Estimated Value	-0.010
	Confidence Interval	(2-Sided) 95%; -0.034 to 0.015
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0124
	Estimation Comments	LS Mean difference was calculated as Test minus Control

2. Secondary Outcome

Title	CLUE Vision
Description	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. The average CLUE vision score for each lens type was reported.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Senofilcon A C3	Delefilcon A
Arm/Group Description	Subjects that wore the Test lens in either of the three study periods.	Subjects that wore the Control lens in either of the three study periods.
Measure Participants	64	64
Mean (Standard Deviation) [units on a scale]	55.34 (20.468)	55.50 (20.422)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A C3, Delefilcon A
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority was declared if the lower limit of the 95% confidence interval for the least-square mean difference was greater than -5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	least-square mean difference
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -4.6 to 4.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.34
	Estimation Comments	LS Mean difference was calculated as Test minus Control

Adverse Events

Time Frame	Throughout the duration of the study; approximately 22-32 days per subject.
Arm/Group Title	Senofilcon A C3		Delefilcon A
Arm/Group Description	Subjects that wore the Test lens in either of the three study periods.		Subjects that wore the Control lens in either of the three study periods.
All Cause Mortality
	Senofilcon A C3		Delefilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/70 (0%)
Serious Adverse Events
	Senofilcon A C3		Delefilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/70 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon A C3		Delefilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/70 (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.