Study to Evaluate the Clinical Performance of SynergEyes A2 Hybrid Contact Lenses

Synergeyes

Status

Unknown

Conditions

Refractive Errors

Astigmatism

Treatments

Device: SynergEyes A2 Hybrid Contact Lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01058629

SI 09-01

Details and patient eligibility

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

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Be able to understand and be willing to sign a written informed consent form
Age ≥18 years
Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specific appointments
Have naturally occurring myopia up to -6.00 D or hyperopia up to +2.00 D (spectacle plane) with or without corneal astigmatism up to 6.00 D
Be in good general health, based on his/her knowledge, including normal healthy eyes
Possess wearable and visually functional eyeglasses
Have manifest refraction visual acuity equal to or better than 20/25 in each eye

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:
- Evidence of corneal ulcer, corneal infiltrates or fungal infections
- Corneal scars within the visual axis
- Pterygium
- Dry eye symptoms with decrease tear levels and punctuate staining ≥ Grade 2
- Neovascularization or ghost vessels ≥1.5mm in from the limbus
- Seborrhoeic eczema or seborrhoeic conjunctivitis
- History of papillary conjunctivitis that has interfered with lens wear or a current condition of Grade 2 or greater
Clinically significant (Grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids or associated structures