Clinical trial NCT04954833: Evaluating Visual Acuity and Initial Fit Performance of Two Soft Contact Lenses
Official title: Evaluating Visual Acuity and Initial Fit Performance of Two Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, controlled, double-masked, 2x2 cross-over, non-dispensing study to compare visual acuity and lens fit performance.


Eligibility criteria: Inclusion Criteria:

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

  1. The subject's parents or legal guardians must read, understand, and sign the STATEMENT OF INFORMED CONSENT (Parental Permission Form and Authorization to Use and Disclose Medical Information). The subject must read (or be read to) and sign the CHILDREN'S ASSENT (Information and Assent Form) 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. Between 7 and 12 (inclusive) years of age at the time of screening.
  4. Have normal eyes (i.e., no ocular medications or infections of any type).
  5. Have non-vertex corrected subjective spherical distance refraction in the range of -0.75 D to -4.50 D (inclusive) in each eye.
  6. Have refractive cylinder in the range of 0.00 D to -1.00 D (inclusive) in each eye with any degree of axis, by subjective sphero-cylindrical refraction.
  7. Have sphero-cylindrical best-corrected visual acuity of 0.04 logMAR (20/20-2) or better in each eye, and the difference of sphero-cylindrical best-corrected visual acuity between the two eyes is less than 0.20 logMAR (2 lines).
  8. Have \< 1.50 D difference in subjective best-sphere refraction between the two eyes.

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

  1. Currently pregnant or lactating.
  2. Have any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., rheumatoid arthritis), any underlying medical condition that makes subjects at risk of severe COVID complications, or other diseases, by parent of legal guardian's self-report, which are known to interfere with contact lens wear and/or participation in the study.
  3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study.
  4. Any current use of ocular medication (occasional use of re-wetting drops is allowed).
  5. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  6. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  7. Current or recent (within 60 days from enrollment) wear of orthokeratology lenses.
  8. Current or recent (within 30 days from enrollment) rigid lens wearers.
  9. Immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  10. Children who are wards of the State or any other agency, institution, or entity.
  11. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration.
  12. Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale.
  13. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear or subjects' participation in the study.
  14. Any central corneal scar.
  15. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear.
  16. Binocular vision abnormality, intermittent strabismus or strabismus.
  17. Pupil diameter under bright illumination is less than 2 mm in either eye.

Primary outcomes:
measure: Monocular Distance Visual Acuity (logMAR)
timeFrame: 10 minutes post lens insertion
Secondary outcomes:
measure: Percentage of Subjects' Eyes With Acceptable Lens Fit
timeFrame: 10 minutes post lens insertion
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: William J. Bogus, OD
state: Utah
Study officials:
References: