Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses
This trial is active, not recruiting.
|Treatments||vistakon marketed contact lens (test), competitor marketed contact lens (control)|
|Start date||September 2015|
|End date||February 2016|
|Trial size||450 participants|
|Trial identifier||NCT02595502, CR-5743|
The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Montgomery, AL||Becky Bizzle, OD||no longer recruiting|
|Fruit Cove, FL||Complete Family Eye Care of Fruit Cove||no longer recruiting|
|Sarasota, FL||Golden Family Eyecare||no longer recruiting|
|Tampa, FL||St. Lucy's Vision Center||no longer recruiting|
|Winter Park, FL||Eye Associates of Winter Park||no longer recruiting|
|Roswell, GA||VisualEyes, Inc.||no longer recruiting|
|Neodesha, KS||Advantage Eyecare Associates, LLC||no longer recruiting|
|Vestal, NY||Sacco Eye Group||no longer recruiting|
|Denver, NC||Advanced Family Eye Care||no longer recruiting|
|Memphis, TN||total Eye Care PA||no longer recruiting|
|Jacksonville, TX||Brian Frazier, OD||no longer recruiting|
|Roanoke, VA||Timothy R. Poling, OD||no longer recruiting|
|West Allis, WI||Ziegler Leffingwell Eyecare||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||single blind (subject)|
time frame: 1 Week
time frame: Week 2 and Week 3
Male or female participants from 18 years up to 39 years old.
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between (and including) 18 and 39 years of age.
- The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
- The subject must have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -0.50 to -6.00 Diopters (D) in each eye.
- The subject must have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
- Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any autoimmune disease or use of medication, which may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, 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.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Monovision, multi-focal, toric, or extended wear contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.
- Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
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