Study of Soft Contact Lens Use With 7 Day Extended Wear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00597467
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : December 22, 2008
Information provided by:
Coopervision, Inc.

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
Ametropia Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens Device: Acuvue 2 Soft Contact Lens Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 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 : March 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: 1 Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens
Test device
Other Name: Biofinity (comfilcon A)

Active Comparator: 2 Device: Acuvue 2 Soft Contact Lens
Control device

Primary Outcome Measures :
  1. 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 [ Time Frame: Pre-dispensing, dispensing and 24 hr, 1 week, and months 1, 2, 3, 6, 9 and 12 ]

Secondary Outcome Measures :
  1. Non-significant adverse events; discontinuations; slit lamp findings; subjective symptoms, problems and complaints; keratometric and refractive changes; and best-corrected visual acuity [ Time Frame: Pre-dispensing, dispensing and 24 hr, 1 week, and months 1, 2, 3, 6, 9 and 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  10. Known sensitivity to the care systems used in this study.
  11. Poor personal hygiene
  12. Current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months.
  13. Any active participation in another clinical study within 30 days prior to this study.
  14. 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.

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 identifier (NCT number): NCT00597467

  Show 23 Study Locations
Sponsors and Collaborators
Coopervision, Inc.
Study Director: William Gleason, OD FRS

Responsible Party: Lisa Hahn, Coopervision, Inc. Identifier: NCT00597467     History of Changes
Other Study ID Numbers: CVI060105
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: December 22, 2008
Last Verified: December 2008

Keywords provided by Coopervision, Inc.:
extended wear

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases