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

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04889625
• Collaborator: (none)
• Enrollment: 81
• Locations: 6
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site: 13.5
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

This is a single-masked, 2×3 crossover, randomized controlled, dispensing clinical trial to evaluate the visual performance (logMAR) and subjective vision responses of the Test Lens.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: senofilcon A C3; Device: Dailies Total 1® Multifocal Contact Lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 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 in Myopes
• Actual Study Start Date: May 21, 2021
• Actual Primary Completion Date: Jul 21, 2021
• Actual Study Completion Date: Jul 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test/Control/Control Eligible subjects will be randomized to one of two possible lens wear sequences, Test/Control/Control.	Device: senofilcon A C3; Test Lens; Device: Dailies Total 1® Multifocal Contact Lenses; Control Lens
Experimental: Control/Test/Test Eligible subjects will be randomized to one of two possible lens wear sequences, Control/Test/Test.	Device: senofilcon A C3; Test Lens; Device: Dailies Total 1® Multifocal Contact Lenses; Control Lens

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [1-Week Follow-up]

   Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast (HLHC) lighting condition 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 meters), 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. 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.

Secondary Outcome Measures

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

   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.

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 section 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. Any current ocular infection or inflammation.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vue Optical Boutique	Jacksonville	Florida	United States	32205
2	St. Johns Eye Associates	Saint Augustine	Florida	United States	32092
3	Sacco Eye Group	Vestal	New York	United States	13850
4	Procare Vision Centers	Granville	Ohio	United States	43023
5	Gulf Coast Vision Center	Houston	Texas	United States	77054
6	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 - Apr 23, 2021

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT04889625
• Other Study ID Numbers: CR-6444
• First Posted: May 17, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jun 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 81 subjects were enrolled in this study. Of those enrolled, 78 were dispensed at least one study lens while, 3 subjects failed to meet all eligibility criteria. Of those enrolled, 68 completed the study while 10 subjects were discontinued from the study.

Arm/Group Title	Senofilcon A (C3) / Delefilcon A / Delefilcon A	Delefilcon A / Senofilcon A (C3) / Senofilcon A (C3)
Arm/Group Description	Subjects that wore the senfilcon A lens during the first period and the delefilcon A lens during the second and third period.	Subjects that wore the delefilcon A lens during the first period and the senofilcon A lens during the second and third period
Period Title: Period 1
STARTED	40	38
COMPLETED	37	34
NOT COMPLETED	3	4
Period Title: Period 1
STARTED	37	34
COMPLETED	35	33
NOT COMPLETED	2	1
Period Title: Period 1
STARTED	35	33
COMPLETED	35	33
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dispensed Subjects
Arm/Group Description	All subjects dispensed a study lens.
Overall Participants	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.4 (5.96)
Sex: Female, Male (Count of Participants)
Female	64 82.1%
Male	14 17.9%
Race/Ethnicity, Customized (participants) [Number]
Asian	1 1.3%
Black or African American	16 20.5%
White	61 78.2%
Region of Enrollment (Count of Participants)
United States	78 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast (HLHC) lighting condition 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 meters), 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. 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.
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 senofilcon A lens during any of the three study periods.	Subjects that wore the delefilcon A lens during any of the three study periods.
Measure Participants	66	66
Distance (4m)	-0.13 (0.097)	-0.13 (0.088)
Intermediate (64cm)	-0.04 (0.105)	-0.01 (0.106)
Near (40cm)	0.07 (0.134)	0.09 (0.128)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A (C3), Delefilcon A
	Comments	Distance (4m)
	Type of Statistical Test	Non-Inferiority
	Comments	This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	least-square mean difference
	Estimated Value	0.000
	Confidence Interval	(2-Sided) 95%; -0.017 to 0.017
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0085
	Estimation Comments	Mean difference was calculated as senofilcon A - delefilcon A

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A (C3), Delefilcon A
	Comments	Intermediate (64cm)
	Type of Statistical Test	Non-Inferiority
	Comments	This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	least-square mean difference
	Estimated Value	-0.030
	Confidence Interval	(2-Sided) 95%; -0.051 to -0.008
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0108
	Estimation Comments	Mean difference was calculated as senofilcon A - delefilcon A

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A (C3), Delefilcon A
	Comments	Near (40cm)
	Type of Statistical Test	Non-Inferiority
	Comments	This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	least-square mean difference
	Estimated Value	-0.036
	Confidence Interval	(2-Sided) 95%; -0.062 to -0.011
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0129
	Estimation Comments	Mean difference was calculated as senofilcon A - delefilcon A

2. Secondary Outcome

Title	Overall Vision
Description	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.
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 senofilcon A lens during any of the three study periods.	Subjects that wore the delefilcon A lens during any of the three study periods.
Measure Participants	66	66
Mean (Standard Deviation) [units on a scale]	59.11 (20.266)	52.84 (19.457)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A (C3), Delefilcon A
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	This study was powered to demonstrate the primary hypotheses. However, the final sample size calculation was deemed large enough to test for Non-inferiority of the Test relative to the Control. A non-inferiority margin of -5 points was used.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	least-square mean difference
	Estimated Value	6.3
	Confidence Interval	(2-Sided) 95%; 2.0 to 10.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.12
	Estimation Comments	Mean difference was calculated as senofilcon A (C3)- delefilcon A

Adverse Events

Time Frame	Throughout the duration of the study. Approximately 1 month per subject.
Arm/Group Title	Senofilcon A (C3)		Delefilcon A
Arm/Group Description	Subjects that wore the senofilcon A lens during any of the three study periods.		Subjects that wore the delefilcon A lens during any of the three study periods.
All Cause Mortality
	Senofilcon A (C3)		Delefilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/75 (0%)
Serious Adverse Events
	Senofilcon A (C3)		Delefilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon A (C3)		Delefilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/75 (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.