Clinical trial NCT05601544: The Effects of Contact Lenses With UV/HEV-Filter on Visual Function
Official title: The Effects of Contact Lenses With UV/HEV-Filter on Visual Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-01
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.).

Primary outcomes:
measure: Visual Range at Phase 1
timeFrame: Approximately 15 minutes post lens fitting
measure: Visual Range at Phase 2
timeFrame: Approximately 15 minutes post lens fitting
measure: Motion Detection at Phase 1
timeFrame: Approximately 15 minutes post lens fitting
measure: Brightness Perception at Phase 1
timeFrame: Approximately 15 minutes post lens fitting
Secondary outcomes:
measure: Motion Detection at Phase 2
timeFrame: Approximately 15 minutes post lens fitting
measure: Brightness Perception at Phase 2
timeFrame: Approximately 15 minutes post lens fitting
Other outcomes:
Locations:
city: Athens
country: United States
facility: The University of Georgia
state: Georgia
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: