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

Astigmatism Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01058629
• Other study ID #: SI 09-01
• Status: Active, not recruiting
• Phase: N/A
• First received: January 26, 2010
• Last updated: August 24, 2010
• Start date: August 2009
• Est. completion date: September 2010

Study information

• Verified date: August 2010
• Source: SynergEyes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Refractive Errors

Intervention

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.

Locations

Country	Name	City	State
United States	Primary Eyecare Group	Brentwood	Tennessee
United States	Family Eye Care Center	Campbell	California
United States	SynergEyes, Inc.	Carlsbad	California
United States	VisionCare Associates, PC	East Lansing	Michigan
United States	Encino Optometric Center Corp.	Encino	California
United States	Specialty Eyecare Group Totem Lake Vision Center	Kirkland	Washington
United States	Snowy Range Vision Center	Laramie	Wyoming
United States	Eyesite	Penfield	New York
United States	Carmel Mountain Vision Care	San Diego	California
United States	The Koetting Associates	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
SynergEyes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirm current SynergEyes A2 lens design by evaluating clinical performance using objective and subjective parameters		6 months	No
Secondary	Determine the best method for fitting the SynergEyes A2 hybrid contact lens		6 months	No