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

Sponsor

SynergEyes, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01058629

Collaborator

(none)

125

Enrollment

Locations

Arm

Duration (Months)

12.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors Astigmatism	Device: SynergEyes A2 Hybrid Contact Lens	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

125 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2010

Anticipated Study Completion Date :

Sep 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Confirm current SynergEyes A2 lens design by evaluating clinical performance using objective and subjective parameters [6 months]

Secondary Outcome Measures

Determine the best method for fitting the SynergEyes A2 hybrid contact lens [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Family Eye Care Center	Campbell	California	United States	95008
2	SynergEyes, Inc.	Carlsbad	California	United States	92008
3	Encino Optometric Center Corp.	Encino	California	United States	91436
4	Carmel Mountain Vision Care	San Diego	California	United States	92129
5	VisionCare Associates, PC	East Lansing	Michigan	United States	48823
6	The Koetting Associates	St. Louis	Missouri	United States	63144
7	Eyesite	Penfield	New York	United States	14526
8	Primary Eyecare Group	Brentwood	Tennessee	United States	37027
9	Specialty Eyecare Group Totem Lake Vision Center	Kirkland	Washington	United States	98034
10	Snowy Range Vision Center	Laramie	Wyoming	United States	82070