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

A 180 Day, Multicenter Study to Evaluate the Clinical Performance of SynergEyes A2 Hybrid Contact Lenses for Daily Wear Use in the Correction of Refractive Error With or Without Astigmatism in Non-diseased Eyes

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

Study Overview

• Status: Unknown
• Conditions: Refractive Errors; Astigmatism
• Intervention / Treatment: Device: SynergEyes A2 Hybrid Contact Lens

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.

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Family Eye Care Center
    • Carlsbad, California, United States, 92008
      • SynergEyes, Inc.
    • Encino, California, United States, 91436
      • Encino Optometric Center Corp.
    • San Diego, California, United States, 92129
      • Carmel Mountain Vision Care
  • Michigan
    • East Lansing, Michigan, United States, 48823
      • VisionCare Associates, PC
  • Missouri
    • St. Louis, Missouri, United States, 63144
      • The Koetting Associates
  • New York
    • Penfield, New York, United States, 14526
      • Eyesite
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Primary Eyecare Group
  • Washington
    • Kirkland, Washington, United States, 98034
      • Specialty Eyecare Group Totem Lake Vision Center
  • Wyoming
    • Laramie, Wyoming, United States, 82070
      • Snowy Range Vision Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SynergEyes A2 Hybrid Contact Lens	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Confirm current SynergEyes A2 lens design by evaluating clinical performance using objective and subjective parameters	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine the best method for fitting the SynergEyes A2 hybrid contact lens	6 months

Collaborators and Investigators

• Sponsor: SynergEyes, Inc.
• Investigators: Principal Investigator: Paul Kusy, OD, MS, FAAO, SynergEyes, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ANTICIPATED): September 1, 2010
• Study Completion (ANTICIPATED): September 1, 2010

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 26, 2010
• First Posted (ESTIMATE): January 28, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 25, 2010
• Last Update Submitted That Met QC Criteria: August 24, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: astigmatism; contact lens; myopia; Hybrid; hyperopia; near sighted; far sighted
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: SI 09-01