Clincosm LogoSign in Get a demo

Study of Soft Contact Lens Use With 7 Day Extended Wear

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00597467
Collaborator
(none)
460
Enrollment
23
Locations
2
Arms
20
Duration (Months)
20
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens
  • Device: Acuvue 2 Soft Contact Lens
 N/A

Detailed Description

To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses in this open-labeled randomized study.

Study Design

Study Type:
Interventional
Actual Enrollment :
460 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Labeled, Multi-Center, Randomized Investigation of the VISA (Comfilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens for Use in a 7 Day Extended Wear Regimen
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Nov 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test Contact Lenses

VISA (comfilcon A) Silicone Hydrogel Soft contact lens

Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens
Test device
Other Names:
  • Biofinity (comfilcon A)

    		•
    Active Comparator: Control Contact Lenses

    Acuvue 2 Soft Contact Lens

    Device: Acuvue 2 Soft Contact Lens
    Control device

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of serious and significant AEs [1 Year]

      Frequency of serious and significant AEs defined as a composite of infiltrates of higher than grade 2 and/or infiltrates with any overlying staining, peripheral ulcer, and loss of two or more lines of visual acuity at any time during the trial

    Secondary Outcome Measures

    1. Contact Lens Visual Acuity [1 Year]

      Contact lens visual acuity was assessed using LogMAR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

    2. Require lens powers between -0.50 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear lenses in both eyes.

    3. Be correctable to visual acuities of at least 20/25 in each eye with spectacles.

    4. Be in good general health, based on his/her knowledge.

    5. Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments.

    6. Possess wearable and visually functional eyeglasses.

    Exclusion Criteria:

    1. Previously unsuccessful with contact lens wear.

    2. Rigid gas permeable contact lens wear within the past 12 months.

    3. Previous refractive surgery; current or previous orthokeratology treatment.

    4. Subject is wearing lenses in a modified monovision modality (multifocal lens in one eye). NOTE: subjects may not wear monovision lenses at any time during the study unless they are wearing spherical monovision lenses prior to enrollment.

    5. Aphakia, keratoconus or an irregular cornea.

    6. A known history of corneal hypoesthesia

    7. Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.

    8. Ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., Sjögren's syndrome, type II diabetes, etc.

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

    • History of corneal ulcer, corneal infiltrates or fungal infections.

    • Pterygium, pinguecula or corneal scars within the visual axis

    • Pathological dry eye or associated findings (examples: Sjögren's syndrome, lupus erythematosus, sclerodermia)

    • Neovascularization or ghost vessels > 1mm in from the limbus

    • Seborrheic eczema, seborrheic conjunctivitis

    • History of papillary conjunctivitis greater than Grade 2 (Mild)

    • Anterior uveitis or iritis (past or present)

    1. Known sensitivity to the care systems used in this study.

    2. Poor personal hygiene

    3. Current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months.

    4. Any active participation in another clinical study within 30 days prior to this study.

    5. Subject is a member, relative or household member of the office staff, including the investigator(s).

    Subjects must read, indicate understanding of, and sign the Informed Consent Form.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 La Mesa Vision Care Center La Mesa California United States 91941
    2 (Private Practice) San Diego California United States 92123
    3 Drs. Cook, Reeder and Associates San Diego California United States 92129
    4 (Private Practice) Santa Monica California United States 90403
    5 Eye Care Associates, P.C. Fort Collins Colorado United States 80521
    6 Eola Eyes Orlando Florida United States 32801
    7 (Private Practice) Honolulu Hawaii United States 96814
    8 Kato & Shoji Optometrists Honolulu Hawaii United States 96815
    9 Eye Care Associates of Hawaii Waipahu Hawaii United States 96797
    10 Davis Eyecare Associates Oak Lawn Illinois United States 60453
    11 (Private Practice) Andover Massachusetts United States 01810
    12 Vision Care Associates East Lansing Michigan United States 48823
    13 The Koetting Associates Inc. Saint Louis Missouri United States 63144
    14 Concord Ophthalmological Associates Concord New Hampshire United States 03301
    15 Place Optical Company Inc Le Roy New York United States 14482
    16 Quinn Quinn & Associates Athens Ohio United States 45701
    17 Western Reserve Vision Care Beachwood Ohio United States 44122
    18 Ohio State University Columbus Ohio United States 43210
    19 Professional Eye Care Associates Columbus Ohio United States 43215
    20 Primary Eyecare Group, P.C. Brentwood Tennessee United States 37027
    21 (Private Practice) Salt Lake City Utah United States 84106
    22 Twin Lakes Vision Federal Way Washington United States 98023
    23 Snowy Range Vision Center Laramie Wyoming United States 82070

    Sponsors and Collaborators

    • Coopervision, Inc.

    Investigators

    • Study Director: William Gleason, OD, FRS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT00597467
    Other Study ID Numbers:
    • CVI060105
    First Posted:
    Jan 18, 2008
    Last Update Posted:
    Jul 17, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Coopervision, Inc.
    myopia
    hyperopia
    extended wear
    ametropia
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Jul 17, 2020