Refractive ErrorsNCT01058629
Study to Evaluate the Clinical Performance of SynergEyes A2 Hybrid Contact Lenses
A study testing SynergEyes A2 Hybrid Contact Lens in people with Refractive Errors and Astigmatism, run by SynergEyes, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Astigmatism
- What is being tested?
- SynergEyes A2 Hybrid Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2009to Sep 2010
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Primary Eyecare Group
Brentwood, Tennessee, 37027
Family Eye Care Center
Campbell, California, 95008
SynergEyes, Inc.
Carlsbad, California, 92008
VisionCare Associates, PC
East Lansing, Michigan, 48823
Encino Optometric Center Corp.
Encino, California, 91436
Specialty Eyecare Group Totem Lake Vision Center
Kirkland, Washington, 98034
Snowy Range Vision Center
Laramie, Wyoming, 82070
Eyesite
Penfield, New York, 14526
Carmel Mountain Vision Care
San Diego, California, 92129
The Koetting Associates
St Louis, Missouri, 63144
About this study
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
This is a multicenter study to evaluate the clinical performance of the SynergEyes A2 lens in patients with refractive errors with or without astigmatism.
Read the 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
- Being tested
- SynergEyes A2 Hybrid Contact Lens
- Keywords
- Hybrid, contact lens, myopia, hyperopia, near sighted, astigmatism, far sighted
- Medical subject headings
- Refractive Errors, Astigmatism, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynergEyes A2 Hybrid Contact LensDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SynergEyes A2 Hybrid Contact Lens | Experimental | Not described Receives: Device: SynergEyes A2 Hybrid Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm current SynergEyes A2 lens design by evaluating clinical performance using objective and subjective parameters
Measured: 6 months
Secondary outcomes (1)
Determine the best method for fitting the SynergEyes A2 hybrid contact lens
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SynergEyes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Kusy, OD, MS, FAAO, Principal investigator, SynergEyes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058629
- Sponsor's protocol ID
- SI 09-01
- Status last verified
- Aug 2010
- First submitted
- 26 Jan 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No