Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses (2022)

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05480514
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 1.8
• Patients Per Site: 30
• Patients Per Site Per Month: 16.9

Study Details

Study Description

Brief Summary

This is a multi-site, 4-visit, brand-masked, bilateral, 2x2 cross-over dispensing study to evaluate visual acuity.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: TEST LENS; Device: CONTROL LENS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Masking Description: Brand masking: subjects, investigators, and clinical site personnel will be unaware of the identity (brand) of both study lenses.
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses
• Anticipated Study Start Date: Aug 8, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TEST/CONTROL Eligible subjects will be randomized to the wear sequence (TEST/CONTROL) to wear the study lenses during each dispensing period (5 to 7 days) with a wash-out period (2 to 5 days) between wears.	Device: TEST LENS; etafilcon A with cosmetic pattern; Device: CONTROL LENS; Acuvue 1-Day Define Fresh Honey
Experimental: CONTROL/TEST Eligible subjects will be randomized to the wear sequence (CONTROL/TEST) to wear the study lenses during each dispensing period (5 to 7 days) with a wash-out period (2 to 5 days) between wears.	Device: TEST LENS; etafilcon A with cosmetic pattern; Device: CONTROL LENS; Acuvue 1-Day Define Fresh Honey

Outcome Measures

Primary Outcome Measures

1. Distance monocular, high luminance, high contrast visual acuity (logMAR) [up to 1-week follow-up]

   Monocular visual acuity will be measured post-lens fitting using ETDRS Charts under high contrast letters (120 - 200 cd/m2) in bright illuminance (>400 lux) conditions at distance (4 meters).

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 30 days 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:

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. 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	Vital Eyecare Center Limited	Mongkok	Kowloon	Hong Kong
2	Sight Enhancement Center	Yau Ma Tei	Kowloon	Hong Kong

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)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT05480514
• Other Study ID Numbers: CR-6489
• First Posted: Jul 29, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 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

No Results Posted as of Aug 10, 2022