Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03755882
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 27.5

Study Details

Study Description

Brief Summary

This will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study. If a subject is found to meet all eligibility criteria, they will be randomized to one of two lens wear sequences. Each lens type will be worn for approximately 2 weeks.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: ACUVUE® DEFINE™ Vivid Style; Device: LACELLE™ Sparkling Brown	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses
• Actual Study Start Date: Nov 5, 2018
• Actual Primary Completion Date: Dec 26, 2018
• Actual Study Completion Date: Dec 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TEST/CONTROL Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences.	Device: ACUVUE® DEFINE™ Vivid Style; TEST Lens; Other Names: etafilcon A ; Device: LACELLE™ Sparkling Brown; CONTROL Lens; Other Names: helifilcon A
Experimental: CONTROL/TEST Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences.	Device: ACUVUE® DEFINE™ Vivid Style; TEST Lens; Other Names: etafilcon A ; Device: LACELLE™ Sparkling Brown; CONTROL Lens; Other Names: helifilcon A

Outcome Measures

Primary Outcome Measures

1. Visual Performance [Up to 2-Week Follow-up]

   Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain 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.

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. Appear able and willing to adhere to the instructions set forth in this clinical protocol (ie, willing to wear only the study lenses and not use habitual lenses during the study).

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

4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -2.00 D to -7.00 D (inclusive) in each eye.

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

6. Have spherical best corrected logMAR visual acuity (VA) of 0.18 or better in each eye.

7. 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.

8. Must be habitual reusable (2 week, or monthly), cosmetic contact lenses wearers.

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

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

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

7. 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).

8. 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	Sun Yat-Sen University Zhongshan Ophthalmic Center	Guanzhou		China

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 20, 2018

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03755882
• Other Study ID Numbers: CR-6286
• First Posted: Nov 28, 2018
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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 46 subjects were enrolled into this study. Of those enrolled 45 were dispensed at least 1 study lens. Of those dispensed, 41 subjects completed the study while 4 were discontinued.

Arm/Group Title	Test/Control	Control/Test
Arm/Group Description	Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period	Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
Period Title: Period 1
STARTED	23	22
COMPLETED	19	22
NOT COMPLETED	4	0
Period Title: Period 1
STARTED	19	22
COMPLETED	19	22
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Total
Arm/Group Description	All subjects dispensed a study lens
Overall Participants	45
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.6 (2.80)
Sex: Female, Male (Count of Participants)
Female	45 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	45 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
China	45 100%

Outcome Measures

1. Primary Outcome

Title	Visual Performance
Description	Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain 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	Up to 2-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who had successfully completed all visits.

Arm/Group Title	Test (Etafilcon A)	Control (Hefilcon A)
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	45	41
Measure Eyes	90	82
High Luminnance Low Contrast	0.40 (0.074)	0.38 (0.086)
High Luminance High Contrast	-0.09 (0.053)	-0.10 (0.059)
Low Luminance High Contrast with Distance Goggles	-0.10 (0.055)	-0.09 (0.055)

Adverse Events

Time Frame	Throughout the duration of the study. Approximately 5 weeks per subject.
Arm/Group Title	Test (Etafilcon A)		Control (Hefilcon A)
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)		Control (Hefilcon A)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Serious Adverse Events
	Test (Etafilcon A)		Control (Hefilcon A)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Test (Etafilcon A)		Control (Hefilcon A)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (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.