NCT01058629

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 25, 2010

Status Verified

August 1, 2010

Enrollment Period

1.1 years

First QC Date

January 26, 2010

Last Update Submit

August 24, 2010

Conditions

Refractive ErrorsAstigmatism

Keywords

Hybridcontact lensmyopiahyperopianear sightedastigmatismfar sighted

Outcome Measures

Primary Outcomes (1)

  • Confirm current SynergEyes A2 lens design by evaluating clinical performance using objective and subjective parameters

    6 months

Secondary Outcomes (1)

  • Determine the best method for fitting the SynergEyes A2 hybrid contact lens

    6 months

Study Arms (1)

SynergEyes A2 Hybrid Contact Lens

EXPERIMENTAL
Device: SynergEyes A2 Hybrid Contact Lens

Interventions

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.

SynergEyes A2 Hybrid Contact Lens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Family Eye Care Center

Campbell, California, 95008, United States

Location

SynergEyes, Inc.

Carlsbad, California, 92008, United States

Location

Encino Optometric Center Corp.

Encino, California, 91436, United States

Location

Carmel Mountain Vision Care

San Diego, California, 92129, United States

Location

VisionCare Associates, PC

East Lansing, Michigan, 48823, United States

Location

The Koetting Associates

St Louis, Missouri, 63144, United States

Location

Eyesite

Penfield, New York, 14526, United States

Location

Primary Eyecare Group

Brentwood, Tennessee, 37027, United States

Location

Specialty Eyecare Group Totem Lake Vision Center

Kirkland, Washington, 98034, United States

Location

Snowy Range Vision Center

Laramie, Wyoming, 82070, United States

Location

MeSH Terms

Conditions

Refractive ErrorsAstigmatismMyopiaHyperopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Paul Kusy, OD, MS, FAAO

    SynergEyes, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 28, 2010

Study Start

August 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

August 25, 2010

Record last verified: 2010-08

Locations

US(10)