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: June 12, 2014
Last verified: June 2014
  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 is 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 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

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
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: 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: June 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 27, 2014