Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population

Visual Acuity Clinical Trial

Official title:

Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742271
• Other study ID #: CR-6241
• Status: Completed
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2020
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear, subjects will return to their habitual spectacles for one week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 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. Between 18 and 39 (inclusive) years of age at the time of screening.

4. They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any subject who has never been dispensed contact lenses. A subject who had taken part in a non-dispensing clinical study or had been fitted with contact lenses in practice but never went on to actually wear the lenses, is also classified as a 'neophyte'.

5. Habitual spectacles must have resulted from an eye exam within the past six months.

6. The subject must have worn the updated spectacles for at least two weeks.

7. Be a current wearer of prescription spectacles that provide corrected monocular visual acuity of 20/25 or better in each eye.

8. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.

9. The subject's refractive cylinder must be -1.00 D or less in each eye.

10. Have spherocylindrical best corrected distance Snellen 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

1. Currently pregnant or lactating.

2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.

3. Use of systemic medications that have a high likelihood to interfere with contact lens wear (estrogens, antihistamines, anticholinergics, beta-blockers, and psychotropics).

4. Any current use of ocular medication.

5. Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free PureMoist.

6. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

7. Employee or immediate family member of an employee of clinical site (e.g., 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.

9. Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp classification scale.

10. Binocular vision abnormality or strabismus.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• senofilcon A
TEST Lens

Locations

Country	Name	City	State
United States	ABQ Eye Care	Albuquerque	New Mexico
United States	ProCare Vision Centers	Granville	Ohio
United States	Georgia Center for Sight	Greensboro	Georgia
United States	Vue Optical Boutique	Jacksonville	Florida
United States	Atlantic Eye Institute	Jacksonville Beach	Florida
United States	Sabal Eye Care	Longwood	Florida
United States	Baker Vision Care	Macclenny	Florida
United States	Eyecare Professionals of Powell	Powell	Ohio
United States	Advanced Eyecare	Raytown	Missouri
United States	Frazier Vision Inc.	Tyler	Texas
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	Acceptable Lens Fitting	Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling.	4-Week Follow-up