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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by SynergEyes, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
SynergEyes, Inc.
ClinicalTrials.gov Identifier:
NCT01058629
First received: January 26, 2010
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention
Refractive Errors
Astigmatism
Device: SynergEyes A2 Hybrid Contact Lens

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by SynergEyes, Inc.:

Primary Outcome Measures:
  • Confirm current SynergEyes A2 lens design by evaluating clinical performance using objective and subjective parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the best method for fitting the SynergEyes A2 hybrid contact lens [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: August 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058629

Locations
United States, California
Family Eye Care Center
Campbell, California, United States, 95008
SynergEyes, Inc.
Carlsbad, California, United States, 92008
Encino Optometric Center Corp.
Encino, California, United States, 91436
Carmel Mountain Vision Care
San Diego, California, United States, 92129
United States, Michigan
VisionCare Associates, PC
East Lansing, Michigan, United States, 48823
United States, Missouri
The Koetting Associates
St. Louis, Missouri, United States, 63144
United States, New York
Eyesite
Penfield, New York, United States, 14526
United States, Tennessee
Primary Eyecare Group
Brentwood, Tennessee, United States, 37027
United States, Washington
Specialty Eyecare Group Totem Lake Vision Center
Kirkland, Washington, United States, 98034
United States, Wyoming
Snowy Range Vision Center
Laramie, Wyoming, United States, 82070
Sponsors and Collaborators
SynergEyes, Inc.
Investigators
Principal Investigator: Paul Kusy, OD, MS, FAAO SynergEyes, Inc.
  More Information

No publications provided

Responsible Party: Jennifer Callahan, MAS/Manager of Clinical and Regulatory Affairs, SynergEyes, Inc.
ClinicalTrials.gov Identifier: NCT01058629     History of Changes
Other Study ID Numbers: SI 09-01
Study First Received: January 26, 2010
Last Updated: August 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by SynergEyes, Inc.:
Hybrid
contact lens
myopia
hyperopia
near sighted
astigmatism
far sighted

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on November 25, 2014