Study of Soft Contact Lens Use With 7 Day Extended Wear

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

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.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens; Device: Acuvue 2 Soft Contact Lens

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 Type: Interventional
• Enrollment (Actual): 460
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of serious and significant AEs	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	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Lens Visual Acuity	Contact lens visual acuity was assessed using LogMAR	1 Year

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Study Director: William Gleason, OD, FRS

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: December 27, 2007
• First Submitted That Met QC Criteria: January 9, 2008
• First Posted (Estimate): January 18, 2008

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: myopia; hyperopia; ametropia; extended wear
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CVI060105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes