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

Visual Acuity Clinical Trial

Official title:

Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05480514
• Other study ID #: CR-6489
• Status: Completed
• Phase: N/A
• Start date: August 27, 2022
• Est. completion date: November 16, 2022

Study information

• Verified date: December 2023
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 16, 2022
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• TEST LENS
etafilcon A with cosmetic pattern
• CONTROL LENS
Acuvue 1-Day Define Fresh Honey

Locations

Country	Name	City	State
Hong Kong	Vital Eyecare Center Limited	Mongkok	Kowloon
Hong Kong	Sight Enhancement Center	Yau Ma Tei	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Eyes With LogMAR Visual Acuity Less Than 0.176 (20/30 Snellen Acuity)	Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions 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.	5-minutes post-lens-fitting