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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01244516
First received: November 17, 2010
Last updated: September 26, 2013
Last verified: September 2013
  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 Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

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

  • Corneal Staining [ Time Frame: after 2 weeks of contact lens wear ] [ Designated as safety issue: No ]
    Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence will be evaluated.


Secondary Outcome Measures:
  • Overall Subjective Lens Handling [ Time Frame: after 2 weeks of contact lens wear ] [ 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. 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
comafilcon A, base curve 8.60
Device: comfilcon A, BC 8.60
comfilcon A, BC 8.60 soft contact lens

  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.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244516

  Show 35 Study Locations
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01244516     History of Changes
Other Study ID Numbers: CR-201007
Study First Received: November 17, 2010
Results First Received: November 29, 2011
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014