The Effects of Contact Lenses With UV/HEV-Filter on Visual Function

Visual Acuity Clinical Trial

Official title:

The Effects of Contact Lenses With UV/HEV-Filter on Visual Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601544
• Other study ID #: CR-6480
• Status: Completed
• Phase: N/A
• Start date: December 9, 2022
• Est. completion date: November 17, 2023

Study information

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

Clinical Trial Summary

This is a 2-phase, single-site, non-dispensing, randomized, controlled, double-masked, 2x2 crossover study to objectively measure potential benefits of a new UV/HEV filter using psychophysical testing techniques.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• 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:

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 70 (inclusive) years of age at the time of screening.

4. By self-report, habitually wear soft contact lenses (sphere, multifocal, toric) in both eyes in a daily reusable 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. If applicable, those subjects receiving the spherical lenses will need a vertex-corrected distance refraction within the range of -1.00 through -6.00 DS

6. If applicable, those subjects receiving the multifocal lenses will need a vertex-corrected distance refraction within the range of -1.00 through -6.00 DS

7. If applicable, those subjects receiving the toric lenses will need a vertex-corrected distance refraction within the range of -1.50 through -4.00 DS, -0.625 through -1.625 DC, and cylinder axes: 80/90/100, 170/180/10

8. The best corrected, monocular, distance visual acuity must be 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:

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 lenses in an extended wear modality.

6. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.

7. 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.

8. (Phase 2 only): Have participated in Phase 1 of the study.

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).

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:
• ACUVUE OASYS 1-Day
Sphere CONTROL
• ACUVUE OASYS MAX 1-Day
Sphere TEST
• ACUVUE OASYS Multifocal
Multifocal CONTROL
• ACUVUE OASYS MAX 1-Day Multifocal
Multifocal TEST
• ACUVUE OASYS 1-Day for Astigmatism
Toric CONTROL
• senofilcon A based contact lens (toric) with new UV/HEV filter
Toric TEST

Locations

Country	Name	City	State
United States	The University of Georgia	Athens	Georgia

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	Visual Range for Multifocal Wearers	Visual range will be tested for multifocal wearers binocularly at 8 cycles per degree in units of log relative energy (LRE) between 0.00-10.00. Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target.	up to 2-week follow-up
Primary	Visual Range for Sphere Wearers	Visual range will be tested for sphere wearers binocularly at 8 cycles per degree in units of log relative energy (LRE) between 0.00-10.00. Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target.	up to 2-week follow-up
Secondary	Motion Detection	Motion detection will be tested for spherical wearers binocularly in units of mm between 0.00-700.00. Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position.	up to 2-week follow-up
Secondary	Brightness Perception	Brightness perception will be tested for multifocal wearers binocularly in units of log relative energy (LRE) between 0.00-10.00. Brightness perception is defined as the log relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes.	up to 2-week follow-up