Clinical Performance of Senofilcon A Investigational Lens

Visual Acuity Clinical Trial

Official title:

Clinical Performance of Senofilcon A Investigational Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300763
• Other study ID #: CR-6481
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: May 25, 2022

Study information

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

Clinical Trial Summary

This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing, bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6 hours per day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• 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:

The subject must:

1. 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. Be between 18 and 39 (inclusive) years of age at the time of screening.

4. By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily wear or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.

5. Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.

6. Possess a wearable pair of spectacles that provide correction for distance vision.

Inclusion Criteria at Baseline Evaluation

7. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye.

8. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 and 1.00 DC (inclusive) in each eye.

9. The best corrected, monocular, distance visual acuity must be 20/25or better in each eye.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study: Exclusion Criteria after Screening

The subject must not:

1. Be currently pregnant or lactating.

2. Be currently using any ocular medications or have any ocular infection of any type.

3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.

4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.

5. Be currently wearing monovision or multifocal contact lenses.

6. Be currently wearing lenses in an extended wear modality.

7. Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment.

8. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. Exclusion Criteria at Baseline Evaluation

The subject must not:

9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). (Specify method of determination if needed).

10. Have a history of strabismus or amblyopia.

11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.

12. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• senofilcon A prototype
Test
• Dailies Total 1
Control

Locations

Country	Name	City	State
United States	Birmingham Vision Care	Bloomfield	Michigan
United States	ProCare Vision Centers	Granville	Ohio
United States	Dr. James Weber & Associates, PA - City Square Blvd	Jacksonville	Florida
United States	Stam & Associates Eye Care	Jacksonville	Florida
United States	Vue Optical Boutique	Jacksonville	Florida
United States	Sabal Eye Care	Longwood	Florida
United States	Maitland Vision Center - North Orlando Ave	Maitland	Florida
United States	Optometry Group, LLC	Memphis	Tennessee
United States	Total Eye Care	Memphis	Tennessee
United States	Flora Chen Poveda, OD, PA - Orange Park	Orange Park	Florida
United States	Southwest Orlando Eye Care	Orlando	Florida
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	VisualEyes	Roswell	Georgia
United States	Botetourt Eyecare, LLC	Salem	Virginia
United States	Randall Go, OD	San Francisco	California
United States	Tallahassee Eye Center	Tallahassee	Florida
United States	Tyler Eye Associates	Tyler	Texas
United States	Sacco Eye Group	Vestal	New York
United States	Dr. David W. Ferris & Associates	Warwick	Rhode Island

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	End of Day Comfort	End of day comfort was assessed using an individual item "Comfort at the End of the Day". Response set: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, and Very Dissatisfied.	2-Week Follow-up
Secondary	Digital Device Use	Lens performance in digital device use was assessed using an individual item "Reduction in the feeling of tired eyes from using a computer or other digital device". Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. "Not Applicable" was excluded from the analysis.	2-Week Follow-up
Secondary	Comfort Throughout the Day	Comfort throughout the day was measured using an individual item "I could wear these contact lenses comfortably for as long as I wanted to". Response set: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree.	2-Week Follow-up
Secondary	Comfortable Vision While Night Driving	Comfortable vision while night driving was assessed using an individual item "Ability to see comfortably while driving at night". Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. "Not Applicable" was excluded from the analysis.	2-Week Follow-up