Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04529109
• Collaborator: (none)
• Enrollment: 58
• Locations: 4
• Arms: 2
• Actual Duration (Months): 1.1
• Patients Per Site: 14.5
• Patients Per Site Per Month: 13.4

Study Details

Study Description

Brief Summary

This will be a randomized, double-masked, bilateral, cross-over, 2 treatment by 2 period dispensing study. There will be 4 visits. There will be a 2 to 5 day washout period between treatments.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: etafilcon A investigational cosmetic lens 1; Device: etafilcon A investigational cosmetic lens 2	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses
• Actual Study Start Date: Aug 13, 2020
• Actual Primary Completion Date: Sep 15, 2020
• Actual Study Completion Date: Sep 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test/Control Eligible subjects that are habitual soft contact lens wearers and current wearers of circle/cosmetic contact lenses will be randomized into lens wear sequence (Test/Control).	Device: etafilcon A investigational cosmetic lens 1; TEST; Device: etafilcon A investigational cosmetic lens 2; CONTROL
Experimental: Control/Test Eligible subjects that are habitual soft contact lens wearers and current wearers of circle/cosmetic contact lenses will be randomized into lens wear sequence (Control/Test).	Device: etafilcon A investigational cosmetic lens 1; TEST; Device: etafilcon A investigational cosmetic lens 2; CONTROL

Outcome Measures

Primary Outcome Measures

1. Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR [5- Minutes Post-Lens Fitting]

   Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition 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. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 29 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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. Females between 18 and 29 (inclusive) years of age at the time of screening

3. Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e. willing to wear only the study lenses and not use habitual lenses during the dispensing periods)

4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report

5. Be a current wearer of cosmetic/circle lenses in the last 6 months, by self-report.

6. The subject must be willing to be photographed and/or video-taped

7. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye

8. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye

9. Have spherical best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating

2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion)

3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion)

4. Any previous or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).

5. Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigators discretion).

6. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment

7. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician)

8. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigators discretion)

9. Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stam & Associates Eye Care	Jacksonville	Florida	United States	32256
2	Frazier Vision, Inc	Tyler	Texas	United States	75703
3	Vital Eyecare Center	Mongkok	Kowloon	Hong Kong
4	Sight Enhancement Center	Yau Ma Tei	Kowloon	Hong Kong

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 28, 2020

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT04529109
• Other Study ID Numbers: CR-6395
• First Posted: Aug 27, 2020
• Last Update Posted: Nov 24, 2021
• Last Verified: Oct 1, 2021

• 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 58 subjects were enrolled into this study. Of those enrolled, 56 were dispensed at least 1 study lens, while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 55 subjects completed the study while 1 subject was discontinued.

Arm/Group Title	Test/Control	Control/Test
Arm/Group Description	Subjects randomized to receive the Test lens during the first period and then receive the Control lens during the second period. Note: Washout period between periods 1 and 2 is considered period 1.	Subjects randomized to receive the Control lens during the first period and then received the Test lens during the second period. Note: Washout period between periods 1 and 2 is considered period 1.
Period Title: Period 1
STARTED	27	29
COMPLETED	27	28
NOT COMPLETED	0	1
Period Title: Period 1
STARTED	27	28
COMPLETED	27	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Total
Arm/Group Description	All subjects who were dispensed a study lens.
Overall Participants	56
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.1 (2.42)
Sex: Female, Male (Count of Participants)
Female	56 100%
Male	0 0%
Race/Ethnicity, Customized (participants) [Number]
Asian	41 73.2%
American Indian or Alaska Native	1 1.8%
Black or African American	4 7.1%
White	9 16.1%
Other	1 1.8%
Region of Enrollment (participants) [Number]
United States	17 30.4%
China	39 69.6%

Outcome Measures

1. Primary Outcome

Title	Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR
Description	Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition 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. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported.
Time Frame	5- Minutes Post-Lens Fitting

Outcome Measure Data

Analysis Population Description

All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Arm/Group Title	Test (Etafilcon A With Cosmetic Pattern)	Control (Etafilcon A With Cosmetic Pattern)
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.	Subjects that wore the Control lens in either the first or second period of the study.
Measure Participants	51	51
Measure Eyes	102	102
Number [proportion of eyes]	0.9998	0.9998

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test (Etafilcon A With Cosmetic Pattern)
	Comments
	Type of Statistical Test	Superiority
	Comments	The superiority of the Test lens was concluded if the lower limit of the 95% credible interval was above 0.90.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Proportion
	Estimated Value	0.9998
	Confidence Interval	(2-Sided) 95%; 0.999 to 1.000
	Parameter Dispersion	Type: Standard Deviation; Value: 0.0005
	Estimation Comments	Interval presented is a 95% Credible interval.

Adverse Events

Time Frame	Throughout the duration of the study. Approximately 3 weeks per subject.
Arm/Group Title	Test (Etafilcon A With Cosmetic Pattern)		Control (Etafilcon A With Cosmetic Pattern)
Arm/Group Description	Subjects that wore the Test lens in either the first or second period of the study.		Subjects that wore the Control lens in either the first or second period of the study.
All Cause Mortality
	Test (Etafilcon A With Cosmetic Pattern)		Control (Etafilcon A With Cosmetic Pattern)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/56 (0%)
Serious Adverse Events
	Test (Etafilcon A With Cosmetic Pattern)		Control (Etafilcon A With Cosmetic Pattern)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Test (Etafilcon A With Cosmetic Pattern)		Control (Etafilcon A With Cosmetic Pattern)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/56 (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.