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

This study has been completed.
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01151371
First received: March 24, 2010
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Myopia
Device: narafilcon B contact lens
Device: nelfilcon A contact lens
Device: lotrafilcon B contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Overall Comfort Narafilcon B v. Nelfilcon A [ Time Frame: After 1 week ] [ Designated as safety issue: No ]
    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.

  • Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]
    Redness scale of 0 to 4, where 0=None, 4=Severe redness

  • Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]
    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.

  • Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]
    Redness scale of 0 to 4, where 0=None, and 4=Severe.


Secondary Outcome Measures:
  • Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]
    Standard scale of 0 to 3 where 0=None, 3=Severe staining

  • Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]
    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.

  • Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]
    Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort

  • Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]
    Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.

  • Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]
    Scale of 0 to 3, where 0=none and 3=severe staining.

  • Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]
    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.

  • Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]
    Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort

  • Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]
    Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.


Enrollment: 452
Study Start Date: February 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151371

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

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01151371     History of Changes
Other Study ID Numbers: CR-0917
Study First Received: March 24, 2010
Results First Received: September 15, 2011
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014