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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

January 26, 2010
August 24, 2010
August 2009
September 2010   (final data collection date for primary outcome measure)
Confirm current SynergEyes A2 lens design by evaluating clinical performance using objective and subjective parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058629 on ClinicalTrials.gov Archive Site
Determine the best method for fitting the SynergEyes A2 hybrid contact lens [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Refractive Errors
  • Astigmatism
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.
Experimental: SynergEyes A2 Hybrid Contact Lens
Intervention: Device: SynergEyes A2 Hybrid Contact Lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
125
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01058629
SI 09-01
No
Jennifer Callahan, MAS/Manager of Clinical and Regulatory Affairs, SynergEyes, Inc.
SynergEyes, Inc.
Not Provided
Principal Investigator: Paul Kusy, OD, MS, FAAO SynergEyes, Inc.
SynergEyes, Inc.
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP