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

Johnson & Johnson (J&J)

Status: Terminated

Conditions: Refractive Error Correction

Treatments: Device: Control/Test; Device: Test/Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT03605303

CR-6270

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

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 of investigational clinic (e.g., Investigator, Coordinator, Technician).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

3 participants in 2 patient groups

CONTROL- etafilcon A current molding

Active Comparator group

Description:

1-Day ACUVUE® MOIST

Treatment:

Device: Control/Test

Device: Test/Control

TEST- etafilcon A novel molding

Experimental group

Description:

Investigational Contact Lens

Treatment:

Device: Control/Test

Device: Test/Control