Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens

The objective of the study is to compare the clinical performance of silicone hydrogel daily disposable contact lenses, conventional hydrogel daily disposable contact lenses and silicone hydrogel monthly replacement contact lenses.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: narafilcon B contact lens; Device: nelfilcon A contact lens; Device: lotrafilcon B contact lens

• Study Type: Interventional
• Enrollment (Actual): 452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Brea, California, United States
    • Canoga Park, California, United States
    • Corona, California, United States
  • Connecticut
    • Bridgeport, Connecticut, United States
  • Florida
    • Jacksonville, Florida, United States, 32205
    • Jacksonville, Florida, United States, 32256
    • Tampa, Florida, United States
    • Winter Park, Florida, United States
  • Georgia
    • Roswell, Georgia, United States
  • Indiana
    • Mishawaka, Indiana, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • Missouri
    • Blue Springs, Missouri, United States
    • Independence, Missouri, United States
    • Lake Ozark, Missouri, United States
  • New York
    • New York, New York, United States
  • North Carolina
    • Raleigh, North Carolina, United States
  • Ohio
    • Chagrin Falls, Ohio, United States
    • North Olmsted, Ohio, United States
    • Warren, Ohio, United States
  • Pennsylvania
    • Kittanning, Pennsylvania, United States
    • State College, Pennsylvania, United States
  • Rhode Island
    • Warwick, Rhode Island, United States
  • Tennessee
    • Bartlett, Tennessee, United States
    • Brentwood, Tennessee, United States
  • Texas
    • Tyler, Texas, United States, 75701
    • Tyler, Texas, United States, 75703
  • Vermont
    • Burlington, Vermont, United States
  • Virginia
    • Virginia Beach, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 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 (See separate document).
• Be willing and able to adhere to the instructions set out in the protocol.
• Own a cell phone and be willing to receive text messages during the day.
• Be an existing successful daily wear soft contact lens. 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 vertexed spherical contact lens prescription between -1.00 and -6.00D.
• Have refractive astigmatism less than or equal to 1.00D in both eyes.
• Achieve visual acuity of 6/9 (20/30) or better in each eye.
• Require a visual correction in both eyes (no monofit or monovision allowed).
• Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
• 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 (Grade 3 or 4) 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 (Grade 3 in more than one corneal region per eye).
• Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
• Has had refractive surgery.
• Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
• Abnormal lacrimal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• PMMA(polymethyl methacrylate), hybrid or RGP(rigid gas permeable) lens wear in the previous 8 weeks.

Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).

• 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., HIV (Human immunodeficiency virus)).
• History of chronic eye disease (e.g. glaucoma or ARMD (age related macular degeneration)).
• Pregnancy, lactating or planning a pregnancy at the time of enrolment.
• 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
Experimental: narafilcon B daily disposable 4 weeks; narafilcon B soft contact lenses worn daily on a daily disposable/replacement schedule, for 4 weeks	Device: narafilcon B contact lens; Silicone Hydrogel Daily Disposable Contact Lenses
Active Comparator: nelfilcon A daily disponsable 1 week; nelfilcon A soft contact lenses worn daily on a daily disposable/replacement schedule, for 1 week	Device: nelfilcon A contact lens; Conventional Hydrogel Daily Disposable Contact Lenses
Active Comparator: lotrafilcon B daily wear, monthly replacement, 4-weeks; lotrafilcon B soft contact lenses worn daily on a 1-month replacement schedule, for 4 weeks	Device: lotrafilcon B contact lens; Silicone Hydrogel Monthly Replacement Contact Lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort Narafilcon B v. Nelfilcon A	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 1 week
Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A	Redness scale of 0 to 4, where 0=None, 4=Severe redness	After 1 Week
Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B	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 4 Weeks
Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B	Redness scale of 0 to 4, where 0=None, and 4=Severe.	After 4 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A	Standard scale of 0 to 3 where 0=None, 3=Severe staining	After 1 Week
Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A	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 1 Week
Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A	Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort	After 1 Week
Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A	Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.	After 1 Week
Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B	Scale of 0 to 3, where 0=none and 3=severe staining.	After 4 Weeks
Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B	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 4 Weeks
Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B	Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort	After 4 Weeks
Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B	Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.	After 4 Weeks

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: June 25, 2010
• First Posted (Estimate): June 28, 2010

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-0917

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No