Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats

Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats

This will be a 5-visit, randomized, partially single-masked, bilateral wear, dispensing, 2-treatment × 2-period crossover study with spectacle-wear washout and wash-in periods.

Inclusion Criteria:

• Potential subjects must satisfy of all 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 39 (inclusive) years of age at the time of screening.

  4. By self-report, habitually wear soft contact lenses (sphere or 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 2 days per week during the past 4 weeks.

  5. Possess a wearable pair of spectacles that provide correction for distance vision.

  6. In both eyes, have magnitude of the cylinder component of their vertex-corrected distance refraction greater than or equal to 0.625 DC and less than 1.625 DC.

  7. In both eyes, have the mean sphere of their vertex-corrected distance refraction minus half of the indicated contact lens label cylinder power be between -0.875 to -4.625 DS (inclusive).

  8. For each eye, have the cylinder axis of their distance refraction between 165° and 15° (i.e., 180±15°, inclusive) or between 75° and 105° (i.e., 90±15°, inclusive).

  9. For both eyes, have the sphere power of their habitual spectacles within ±0.50 Diopters Sphere (DS) (inclusive) of the sphere power of their current subjective refraction.

  10. For both eyes, have the cylinder power of their habitual spectacles within ±0.50 Diopters Cylinder (DC) (inclusive) of the cylinder power of their current subjective refraction.

  11. For both eyes, have the cylinder axis of their habitual spectacles within ±20° (inclusive) of the cylinder axis of their current subjective refraction.

  12. Achieve monocular VA of 20/30 or better with their habitual spectacles in both eyes.

      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 or have any ocular infection of any type.
  4. 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.
  5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
  6. Be currently wearing monovision or multifocal contact lenses.
  7. Be currently wearing lenses in an extended wear modality.
  8. Have a history of strabismus or amblyopia.
  9. 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.
  10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  11. 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).
  12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  13. 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.).