Clinical trial NCT05120128: Changes in Inflammatory Biomarkers When Symptomatic Contact Lens Wearers Are Refit in Acuvue Oasys 1-Day Lenses
Official title: Changes in Inflammatory Biomarkers When Symptomatic Contact Lens Wearers Are Refit in Acuvue Oasys 1-Day Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a 5-Visit, single-arm, single-site, subject masked, dispensing trial to evaluate contact lens discomfort and inflammatory biomarker expression.

Detailed description: The study will assess device feasibility for up to 10 habitual wearers of 4 different types of marketed contact lens.

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. Be between 18 and 60 (inclusive) years of age at the time of screening.
  4. By self-report, habitually wear one of four soft spherical contact lens types (1-Day Acuvue Moist, Dailies Aqua Comfort Plus, Dailies Total1, Clariti 1 Day) in both eyes in a daily disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear per day, for a minimum of 4 days per week during the past 4 weeks.
  5. Have a CLDEQ-8 score at pre-screening of 15 or more.
  6. Own a wearable pair of spectacles.
  7. The habitual contact lens sphere correction in each eye must be between -6.00 and -0.50 D or between +0.50 and +4.00 D (inclusive).
  8. The magnitude of the cylinder component of the subject's distance over-refraction must be 1.00 DC or less in each eye.
  9. The subject must have visual acuity of 0.2 high contrast logMAR or better with spherocylinder over-refraction 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 breastfeeding
  2. 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. See Section 9.1 for additional details regarding excluded systemic medications.
  3. Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract etc.).
  4. Habitually wear multi-focal, toric, or extended wear contact lens correction
  5. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
  6. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
  7. Have a history of amblyopia or strabismus.
  8. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg. SynergEyes) within the past 6 months.
  9. Have clinically significant (grade 3 or higher on the Efron grading scale) slit lamp findings (e.g., corneal edema or neovascularization, conjunctival or limbal redness) or any other abnormality which would normally contraindicate contact lens wear
  10. Have any ocular infection.

Primary outcomes:
measure: CLDEQ-8 Score follow up 1
timeFrame: at 1-week follow-up
measure: CLDEQ-8 Score follow up 2
timeFrame: at 2-week follow-up
measure: MMP-9 Expression in Epithelial Cells of Bulbar Conjunctiva
timeFrame: at 1-week follow-up
measure: MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper
timeFrame: at 1-week follow-up
measure: MMP-9 Expression in Epithelial Cells of Bulbar Conjunctiva
timeFrame: at 2-week follow-up
measure: MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper
timeFrame: at 2-week follow-up
Secondary outcomes:
measure: Average difference in CLDEQ-8 scores between Subjects' own lens and AO1D
timeFrame: up to 2-week follow-up
measure: Average Difference in MMP-9 Expression in Epithelial Cells of Bulbar Conjuctiva between Subjects' own lens and AO1D
timeFrame: up to 2 week follow up
measure: Average Difference in MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper between Subjects' own lens and AO1D
timeFrame: up to 2 week follow up
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: