Clinical trial NCT05141448: Visual Performance of Soft Contact Lenses With Myopia Control Optics
Official title: Visual Performance of Soft Contact Lenses With Myopia Control Optics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-02
Enrollment: 79
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a multi-site, bilateral, dispensing, randomized, controlled, single-masked, 3x3 crossover study with a run-in period.


Eligibility criteria: Inclusion Criteria:

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

  1. 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. Have parents or legal guardians who must read, understand, and sign the STATEMENT OF INFORMED CONSENT (Parental Permission Form and Authorization to Use and Disclose Medical Information).
  3. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  4. Be between 7 and 17 (inclusive) years of age at the time of screening.
  5. By self-report, habitually wear soft contact lenses or be a current non-contact lens wearer interested in soft lens wear.
  6. The non-vertex corrected best sphere distance refraction must be between -1.00 D and -4.50 D (inclusive) in each eye.
  7. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be less than or equal to 0.75 D (inclusive) in each eye with any degree of axis.
  8. The distance visual acuity with best sphere distance correction must be 20/25 or better in each eye.
  9. Have ≤ 1.50 D difference in subjective best-sphere refraction between the two eyes.
  10. Have 20/40 or better vision in each eye with wearable spectacles or uncorrected.

      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 diabetic.
  3. Be currently using any ocular medications. Lubricants (artificial tears) eyedrops are allowed.
  4. Have any current ocular infection of any type.
  5. Have any systemic disease (e.g., Sjogren'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, a history of serious mental illness or seizures, or other diseases, by parent or legal guardian's self-report, which are known to interfere with contact lens wear and/or participation in the study.
  6. Use of systemic medication (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study. See section 9.1 for additional details regarding excluded systemic medications.
  7. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 30 days.
  8. Be currently wearing lenses in an extended wear modality.
  9. Be currently wearing soft contact lenses for astigmatism in either eye.
  10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  11. 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.
  12. Children who are wards of the State or any other agency, institution, or entity.
  13. Have 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 is not limited to, entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis.
  14. Have grade 3 or greater palpebral conjunctival observations or any other grade 2 slit lamp findings on the ISO 11980 classification scale.
  15. Have strabismus (intermittent or constant) or amblyopia.
  16. Have a history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar).
  17. Have any central corneal scar.
  18. Have a pupil diameter under bright illumination of less than 2 mm in either eye.

Primary outcomes:
measure: Binocular Visual Performance (LogMAR)
timeFrame: Up to 2-Week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Vision Optique
state: Texas
Study officials:
References: