Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear

Launched by COOPERVISION, INC. · Aug 7, 2019

Keywords

ClinConnect Summary

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.

This is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira Vitality silicone hydrogel Toric lenses (fanfilcon A).

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Is between 18 and 40 years of age (inclusive)
• • Has had a self-reported visual exam in the last two years
• • Is an adapted soft toric contact lens wearer
• • Has a contact lens spherical prescription between +6.00 to -8.00 (inclusive)
• • Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
• • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
• • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
• • Has clear corneas and no active ocular disease
• • Has read, understood and signed the information consent letter.
• • Patient contact lens refraction should fit within the available parameters of the study lenses.
• • Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
• • Is willing to comply with the visit schedule
• Exclusion Criteria:
• • Has a CL prescription outside the range of the available parameters of the study lenses.
• • Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
• • Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
• • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
• • Presence of clinically significant (grade 2-4) anterior segment abnormalities
• • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
• * Slit lamp findings that would contraindicate contact lens wear such as:
• • Pathological dry eye or associated findings
• • Pterygium, pinguecula, or corneal scars within the visual axis
• • Neovascularization \> 0.75 mm in from of the limbus
• • Giant papillary conjunctivitis (GCP) worse than grade 1
• • Anterior uveitis or iritis (past or present)
• • Seborrheic eczema, Seborrheic conjunctivitis
• • History of corneal ulcers or fungal infections
• • Poor personal hygiene
• • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
• • Has aphakia, keratoconus or a highly irregular cornea.
• • Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
• • Has undergone corneal refractive surgery.
• • Is participating in any other type of eye related clinical or research study.