Clinical trial NCT05021081: Visual Performance of Senofilcon A With and Without a New UV/HEV-filter
Official title: Visual Performance of Senofilcon A With and Without a New UV/HEV-filter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Performance
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In Phase 2, subjects will be randomized to a contralateral sequence where the study lenses will be worn throughout the duration of the study.
Primary purpose: TREATMENT

Brief summary: This study will occur in two non-dispensing phases: Phase 1 is a non-randomized, non-masked, non-dispensing study where subjects will wear their own contact lenses for approximately 1 hour. Phase 2 is a controlled, randomized, double-masked, contralateral non-dispensing study where the study lenses will be worn in a daily wear modality for approximately 3 hours.


Eligibility criteria: Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  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. For Phase I be between 18-39 (inclusive) years of age at the time of screening.
  4. For Phase II be between 18 and 70 (inclusive) years of age at the time of screening.
  5. By self-report, habitually wear spherical silicone hydrogel soft contact lenses 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.
  6. Possess a wearable pair of spectacles that provide correction for distance vision.
  7. Habitual spherical contact lens powers must be between -1.00 D and -6.00 D (inclusive) in each eye.
  8. For Phase I, habitual contact lenses must provide at least 20/20 acuity OD and OS.
  9. For Phase II, the spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.
  10. For Phase II, the magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 D and 1.00 D (inclusive) in each eye.
  11. For Phase II, 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:

  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 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.
  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.
  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 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 any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
  13. Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar).
  14. Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid position or movement.

Primary outcomes:
measure: Photopic Contrast Sensitivity at 6 Cpd
timeFrame: Post screening up to 1 hour during Phase 1
measure: Mesopic Contrast Sensitivity at 6 Cpd
timeFrame: Post screening up to 1 hour during Phase 1
measure: Photopic Resolution Acuity Using Landolt C's With a Glare Source
timeFrame: At least 5 minutes post lens fitting up to 2 hours during Phase 2
Secondary outcomes:
measure: Photopic Contrast Sensitivity With a Glare Source
timeFrame: At least 5 minutes post lens fitting up to 2 hours during Phase 2
measure: Mesopic Contrast Sensitivity With a Glare Source
timeFrame: At least 5 minutes post lens fitting up to 2 hours during Phase 2
Other outcomes:
Locations:
city: Athens
country: United States
facility: 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: