Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses

The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: galyfilcon A, BC 8.30; Device: lotrafilcon B, BC 8.60; Device: comfilcon A, BC 8.60

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Brea, California, United States, 92891
    • Campbell, California, United States, 95008
    • Cupertino, California, United States, 95014
    • Mission Viejo, California, United States, 92691
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
  • Florida
    • Aventura, Florida, United States, 33180
    • Jacksonville, Florida, United States, 32256
    • Tallahassee, Florida, United States, 32308
    • Tampa, Florida, United States, 33625
    • Winter Park, Florida, United States, 32792
  • Georgia
    • Roswell, Georgia, United States, 30076
  • Illinois
    • Bloomington, Illinois, United States, 61701
  • Indiana
    • Mishawaka, Indiana, United States, 46545
  • Kansas
    • Pittsburg, Kansas, United States, 66763
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
  • Missouri
    • Independence, Missouri, United States, 64055
    • Raytown, Missouri, United States, 64133
  • New Jersey
    • Closter, New Jersey, United States, 07624
  • New York
    • New York, New York, United States, 10001
  • North Carolina
    • Raleigh, North Carolina, United States, 27615
  • Ohio
    • North Olmsted, Ohio, United States, 44070
    • Powell, Ohio, United States, 43065
  • Pennsylvania
    • Kittanning, Pennsylvania, United States, 16201
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
  • South Dakota
    • Chamberlain, South Dakota, United States, 57325
  • Tennessee
    • Bartlett, Tennessee, United States, 38134
    • Brentwood, Tennessee, United States, 37027
    • Memphis, Tennessee, United States, 38119
  • Texas
    • Tyler, Texas, United States, 75701
    • Tyler, Texas, United States, 75703
  • Utah
    • Salt Lake City, Utah, United States, 84106
  • Vermont
    • Burlington, Vermont, United States, 05401
  • Virginia
    • Salem, Virginia, United States, 24153
    • Virginia Beach, Virginia, United States, 23455

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be no less than 18 and no more than 39 years of age.
• Sign Written Informed Consent and investigator to record this on Case Report Form.
• Be willing and able to adhere to the instructions set out in the protocol.
• Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
• No extended wear in the last 3 months.
• Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.
• Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
• Achieve visual acuity of 6/9 (20/30) or better in each eye.
• Require a visual correction in both eyes (no monovision allowed).
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.

Exclusion Criteria:

• Requires concurrent ocular medication.
• Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
• Clinically significant corneal staining
• Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
• Has had refractive surgery.
• Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
• Abnormal lacrimal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Diabetic.
• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease [e.g., Human immunodeficiency virus (HIV)].
• History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
• Pregnancy, lactating or planning a pregnancy at the time of enrollment.
• Participation in any concurrent clinical trial or in last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: galyfilcon A; Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.	Device: galyfilcon A, BC 8.30; galyfilcon A, BC 8.30 soft contact lens
Other: lotrafilcon B; Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.	Device: lotrafilcon B, BC 8.60; lotrafilcon B, BC 8.60 soft contact lens
Other: comfilcon A; Subjects that were randomized to wear comfilcon A lens throughout the course of the study.	Device: comfilcon A, BC 8.60; comfilcon A, BC 8.60 soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Subjective Comfort	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.	after 2 weeks of contact lens wear
Corneal Staining	Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.	after 2 weeks of contact lens wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Subjective Lens Handling	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.	after 2 weeks of contact lens wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-201007