Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter Study

December 22, 2009 updated by: SynergEyes, Inc.

A 90 Day Multi-Center, Randomized, Parallel Group Daily Wear Investigation of a New Hybrid Lens SynergEyes SA Manufactured With a Rigid Gas Permeable Center (Petrafocon A) and a Silicone Hydrogel Skirt (Larafilcon A) Compared to SynergEyes A (Paflufocon D Hem-iberfilcon A)

The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied:

  • within the corresponding range of lens powers
  • in a population randomized within multiple investigational sites
  • with a study ration of 2/1 test vs control lenses
  • for a duration of 90 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of the study is to compare the SynergEyes SA Hybrid Contact Lens (Test) to the SynergEyes A Hybrid Contact lens (Control) when used in a daily wear regimen on non-diseased eyes for the correction of myopia (-0.25 to -6.00Diopters) with up to -2.50 Diopters of astigmatism. The population will be randomized into a 2/1 ratio of the Test/Control for 90 days. The study objective is to complete at least 40 subjects in the Test material and 20 subjects in the Control material.

The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied within the corresponding range of powers in a population randomized within investigational sites to produce a 2/1 ratio of Test vs. Control lenses.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92129
        • Carmel Mountain Vision Care
      • Sunnyvale, California, United States, 94087
        • Silicon Valley Eye Physicians
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Casazza Optometric Group
    • Michigan
      • East Lansing, Michigan, United States, 48823
        • Vision Care Associates
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Western Reserve Vision Care, Inc.
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Dr. Karambelas & Associates
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
        • Primary Eyecare Group P.C.
    • Wyoming
      • Laramie, Wyoming, United States, 82070
        • Snowy Range Vision Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Prior to being considered eligible to participate in this study, each subject MUST:

  1. Be at least 18 years of age as of the date of evaluation.

  2. Have

    1. read the Informed Consent,
    2. been given an explanation of the Informed Consent,
    3. indicated an understanding of the Informed Consent and
    4. signed the Informed Consent Form.
  3. Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
  4. Be a current contact lens wearer.
  5. Possess wearable and visually functional eyeglasses.
  6. Be in good general health, based on his/her knowledge.
  7. Require spectacle lens powers between plano and -6.00 diopters sphere with no more than -2.50 diopters of spectacle refractive astigmatism and be willing to wear lenses in both eyes.
  8. Have manifest refraction visual acuity equal to or better than 20/25 in each eye.

Exclusion Criteria:

  • Subjects may not be enrolled into the study if ANY of the following apply:

    1. Subject is wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may NOT wear monovision lenses at any time during the study as it will interfere with the distance visual acuity measurement.
    2. Subject exhibits poor personal hygiene.
    3. Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
    4. Subject is currently pregnant (to the best of the subject's knowledge), is planning a pregnancy within the next 3 months or is lactating.
    5. Subject is a member, relative or household member of the office staff, including the investigator(s).
    6. Subject has a known sensitivity to ingredients used in contact lens care products or over-the-counter lubricants and artificial tears.
    7. Subject has undergone refractive surgery or is currently receiving or has previously received orthokeratology treatment.
    8. Subject is aphakic or pseudophakic.
    9. Subject has ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome lupus erythematosus, scleroderma, keratoconus or type II diabetes.
    10. Use of ocular medications for any reason or systemic medications which might interfere with contact lens wear.
    11. A known history of corneal hypoesthesia (reduced corneal sensitivity).

    12. Slit lamp findings that would contraindicate contact lens wear, including but not limited to:

      • History of corneal ulcer, corneal infiltrates or fungal infections
      • Corneal scars within the visual axis
      • Pterygium
      • Dry eye symptoms with decrease tear levels and punctate staining ≥ Grade 2
      • Neovascularization or ghost vessels > 1.5 mm in from the limbus
      • Seborrhoeic eczema, seborrhoeic conjunctivitis
      • History of papillary conjunctivitis that has interfered with lens wear or a current condition of Grade 2 (Mild) or greater
    13. Clinically significant (Grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.

TO BE ELIGIBLE TO BE RANDOMIZED FOR STUDY PRODUCT TRIAL A SUBJECT MUST HAVE ALL OF THE INCLUSION CRITERIA AND NONE OF THE EXCLUSION CRITERIA PRESENT.

TO BE ELIGIBLE FOR LENS DISPENSING, THE SUBJECT'S STUDY DEVICE CONTACT LENS VISUAL ACUITY MUST BE EQUAL TO OR BETTER THAN 20/30 IN EACH EYE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Test arm daily wear hybrid contact lens.
Device: SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens
Comparison to control hybrid lens with similar 'dose'minimum 8 hours daily use for up to 90 days.
Other: 2
Control: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Hybrid Contact Lens
Device: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens
Comparison to test lens: Daily use for minimum 8 hours up to 90 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of objective findings (slit lamp, lens fitting, deposits, subjective symptoms, adverse events test vs control
Time Frame: 3 months
3 months
Visual acuity comparison test/control.
Time Frame: 3 mo.
3 mo.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SynergEyes, Inc.

Investigators

  • Study Director: William Gleason, OD, Foresight Regulatory Strategies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 22, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI-0804 V1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe