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

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ClinicalTrials.gov Identifier: NCT00804505
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : December 23, 2009
Sponsor:
Information provided by:
SynergEyes, Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Corneal Disease Hypersensitivity Device: SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens Device: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens Not Applicable

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  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : June 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

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.
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.



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804505


Locations
United States, California
Carmel Mountain Vision Care
San Diego, California, United States, 92129
Silicon Valley Eye Physicians
Sunnyvale, California, United States, 94087
United States, Massachusetts
Casazza Optometric Group
Andover, Massachusetts, United States, 01810
United States, Michigan
Vision Care Associates
East Lansing, Michigan, United States, 48823
United States, Ohio
Western Reserve Vision Care, Inc.
Beachwood, Ohio, United States, 44122
United States, Rhode Island
Dr. Karambelas & Associates
Providence, Rhode Island, United States, 02906
United States, Tennessee
Primary Eyecare Group P.C.
Brentwood, Tennessee, United States, 37027
United States, Wyoming
Snowy Range Vision Center
Laramie, Wyoming, United States, 82070
Sponsors and Collaborators
SynergEyes, Inc.
Investigators
Study Director: William Gleason, OD Foresight Regulatory Strategies, Inc.

Responsible Party: SynergEyes, Inc., Joe Collins
ClinicalTrials.gov Identifier: NCT00804505     History of Changes
Other Study ID Numbers: SI-0804 V1.0
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by SynergEyes, Inc.:
Substantial equivalence to control device

Additional relevant MeSH terms:
Hypersensitivity
Corneal Diseases
Immune System Diseases
Eye Diseases