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

Refractive Error Correction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03605303
• Other study ID #: CR-6270
• Status: Terminated
• Phase: N/A
• Start date: July 3, 2018
• Est. completion date: July 5, 2018

Study information

• Verified date: August 2019
• 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: Terminated
• Enrollment: 3
• Est. completion date: July 5, 2018
• Est. primary completion date: July 5, 2018
• 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:

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).

Related Conditions & MeSH terms

• Refractive Error Correction
• Refractive Errors

Intervention

Device:
• Test/Control
Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Test/Control sequence with a 7 to 9-day washout period in between treatments
• Control/Test
Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Control/Test sequence with a 7 to 9-day washout period in between treatments

Locations

Country	Name	City	State
United States	Total Eye Care, PA	Memphis	Tennessee

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	Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.	1-Week Follow-up
Primary	Overall Vision Score	Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.	1-Week Follow-up