Phase
Condition
Astigmatism
Treatment
Test Lens
Control Lens
Clinical Study ID
Ages 18-39 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must:
Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be between 18 and 39 (inclusive) years of age at the time of screening.
By self-report, habitually wear 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 2 days per week during the past four weeks.
Possess a wearable pair of spectacles that provide correction for distance vision.
In both eyes, have refractive error suitable for correction with the range of toric contact lens powers available in this study:
6.1 Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps 6.2 Cylinder powers (DC) -0.75 and -1.25 6.3 Axes (°) 170, 180, 10, 80, 90 and 100
- Have best corrected monocular distance visual acuity of 20/25 or better in each eye.
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
The subject must not:
Be currently pregnant or lactating.
Be diabetic.
Be currently using any ocular medications or have any ocular infection of any type.
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.
Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
Be currently wearing monovision or multifocal contact lenses.
Be currently wearing lenses in an extended wear modality.
Have a history of strabismus or amblyopia.
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.
Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
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).
Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
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.).
Study Design
Connect with a study center
Stam & Associates Eye Care
Jacksonville, Florida 32256
United StatesSite Not Available
Omega Vision Center
Longwood, Florida 32779
United StatesSite Not Available
Maitland Vision Center - North Orlando Ave
Maitland, Florida 32751
United StatesSite Not Available
Kannarr Eye Care - 101 North Broadway
Pittsburg, Kansas 66762
United StatesSite Not Available
Birmingham Vision Care
Bloomfield Hills, Michigan 48301
United StatesSite Not Available
Complete Eye Care of Medina
Medina, Minnesota 55340
United StatesSite Not Available
Sacco Eye Group
Vestal, New York 13850
United StatesSite Not Available
Procare Vision Centers
Granville, Ohio 43023
United StatesSite Not Available
Professional Vision Care Inc. - Westerville
Westerville, Ohio 43081
United StatesSite Not Available
Optometry Group, PLLC
Memphis, Tennessee 38111
United StatesSite Not Available
Tyler Eye Associates
Tyler, Texas 75703
United StatesSite Not Available
Botetourt Eyecare, LLC
Salem, Virginia 24153
United StatesSite Not Available
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