Status
Conditions
Treatments
About
This is a multicenter study to evaluate the clinical performance of the SynergEyes A2 lens in patients with refractive errors with or without astigmatism.
Full description
Hybrid contact lenses have been previously shown to be a safe and effective method to correct refractive errors with and without astigmatism. The hybrid contact lens design may provide greater visual acuity and comfort than other soft or rigid gas permeable (RGP) lenses currently available. The purpose of this study is to confirm the design of the SynergEyes A2 lens by evaluating clinical performance and, if necessary, modify certain lens parameters in order to optimize lens performance. Objective and subjective parameters will be used to evaluate the lens.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Subject requires multifocal vision correction or is wearing lenses in a monovision modality
Subject has lenticular astigmatism uncorrectable by normal RGP tear layer optics
Subject exhibits poor personal hygiene
Subject is currently or within 30 days prior to enrollment in this study has been an active participant in another clinical study (except SynergEyes Protocol # SI 08-05)
Subject is currently pregnant (to the best of the subject's knowledge), is planning a pregnancy within the next 9 months, or is lactating
Subject has a known sensitivity to ingredients used in contact lens care products
Subject has undergone refractive surgery or is currently receiving or has previously received orthokeratology treatment
Subject is aphakic or pseudophakic
Subject has ocular or systemic disease such as, but not limited to, anterior uveitis or iritis (past or present), glaucoma, Sjogren's Syndrome, lupus erythematosus, scleroderma, keratoconus, post surgical corneal irregularity or type II diabetes
Subject is using ocular medications for any reason or systemic medications which might interfere with contact lens wear
A known history of corneal hypoesthesia (reduced corneal sensitivity)
Slit lamp findings that would contraindicate contact lens wear, including, but not limited to:
Clinically significant (Grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids or associated structures
Primary purpose
Allocation
Interventional model
Masking
125 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal