Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2

Myopia Clinical Trial

Official title:

Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701516
• Other study ID #: CR-6307
• Status: Completed
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2022
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 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. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.

4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).

5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

6. The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.

7. The subject's refractive cylinder must be < 0.75 D in each eye.

8. The subject must have 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 (subjects who become pregnant during the study will be discontinued).

2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.

3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

4. Any ocular infection.

5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

6. Monovision or multi-focal contact lens correction.

7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.

8. History of binocular vision abnormality or strabismus.

9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).

10. Suspicion of or recent history of alcohol or substance abuse.

11. History of serious mental illness.

12. History of seizures.

13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)

14. 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.

15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale.

16. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• etafilcon A with novel molding process
TEST Lens
• etafilcon A with current molding process
CONTROL Lens

Locations

Country	Name	City	State
United States	Primary Eyecare Group	Brentwood	Tennessee
United States	Fleming Island Vision Center	Fleming Island	Florida
United States	ProCare Vision Centers	Granville	Ohio
United States	Bartram Eye Clinic	Jacksonville	Florida
United States	Sabal Eye Care	Longwood	Florida
United States	Maitland Vision Center	Maitland	Florida
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Eyecare Professionals of Powell	Powell	Ohio
United States	EyeCenter Optometrics	Rocklin	California
United States	St. Johns Eye Associates	Saint Augustine	Florida
United States	Boutetourt Eyecare, LLC	Salem	Virginia
United States	Sacco Eye Group	Vestal	New York

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Comfort Scores	Overall comfort was 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.	1-week Follow-up
Primary	Overall Vision Scores	Overall vision was assessed using the CLUE questionnaire. CLUE is a validated 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 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.	1-week Follow-up
Secondary	Average Daily Wear Time	Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-week follow-up evaluation. Higher wear times indicate better lens performance. The average wear time was reported for each lens type.	1-week Follow-up
Secondary	LLHC LogMAR Visual Performance	Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under low luminance and high contrast conditions (LLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.	1-week Follow-up
Secondary	HLLC LogMAR Visual Performance	Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under high luminance and low contrast conditions (HLLC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.	1-week Follow-up