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

NCT ID: NCT01058629

Last Updated: 2010-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-09-30

Brief Summary

This is a multicenter study to evaluate the clinical performance of the SynergEyes A2 lens in patients with refractive errors with or without astigmatism.

Detailed 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.

Conditions

Refractive Errors; Astigmatism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SynergEyes A2 Hybrid Contact Lens

Group Type: EXPERIMENTAL

SynergEyes A2 Hybrid Contact Lens

Intervention Type: DEVICE

SynergEyes A2 is a hybrid contact lens cleared by the US Food and Drug Administration (FDA) for daily wear correction of up to +20.00 and -20.00 in eyes with astigmatism up to 6.00D and for presbyopia.

Interventions

SynergEyes A2 Hybrid Contact Lens

SynergEyes A2 is a hybrid contact lens cleared by the US Food and Drug Administration (FDA) for daily wear correction of up to +20.00 and -20.00 in eyes with astigmatism up to 6.00D and for presbyopia.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SynergEyes, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

SynergEyes, Inc.

Principal Investigators

Paul Kusy, OD, MS, FAAO

Role: PRINCIPAL_INVESTIGATOR

SynergEyes, Inc.

Locations

Family Eye Care Center

Campbell, California, United States

SynergEyes, Inc.

Carlsbad, California, United States

Encino Optometric Center Corp.

Encino, California, United States

Carmel Mountain Vision Care

San Diego, California, United States

VisionCare Associates, PC

East Lansing, Michigan, United States

The Koetting Associates

St Louis, Missouri, United States

Eyesite

Penfield, New York, United States

Primary Eyecare Group

Brentwood, Tennessee, United States

Specialty Eyecare Group Totem Lake Vision Center

Kirkland, Washington, United States

Snowy Range Vision Center

Laramie, Wyoming, United States

Countries

United States

Other Identifiers

SI 09-01

Identifier Type: -

Identifier Source: org_study_id