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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244516
First Posted: November 19, 2010
Last Update Posted: May 10, 2016
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.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
  Purpose
The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.

Condition Intervention
Myopia Device: galyfilcon A, BC 8.30 Device: lotrafilcon B, BC 8.60 Device: comfilcon A, BC 8.60

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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Overall Subjective Comfort [ Time Frame: after 2 weeks of contact lens wear ]
    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.

  • Corneal Staining [ Time Frame: after 2 weeks of contact lens wear ]
    Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.


Secondary Outcome Measures:
  • Overall Subjective Lens Handling [ Time Frame: after 2 weeks of contact lens wear ]
    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.


Enrollment: 540
Study Start Date: September 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
galyfilcon A
galyfilcon A base curve 8.30
Device: galyfilcon A, BC 8.30
galyfilcon A, BC 8.30 soft contact lens
lotrafilcon B
lotrafilcon B, base curve 8.60
Device: lotrafilcon B, BC 8.60
lotrafilcon B, BC 8.60 soft contact lens
comfilcon A
comfilcon A, base curve 8.60
Device: comfilcon A, BC 8.60
comfilcon A, BC 8.60 soft contact lens

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
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.
  • 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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01244516


  Show 35 Study Locations
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01244516     History of Changes
Other Study ID Numbers: CR-201007
First Submitted: November 17, 2010
First Posted: November 19, 2010
Results First Submitted: November 29, 2011
Results First Posted: January 24, 2012
Last Update Posted: May 10, 2016
Last Verified: April 2016