Performance of Two Silicone Hydrogel Toric Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00638846
First received: March 10, 2008
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.


Condition Intervention
Vision Correction
Device: senofilcon A toric
Device: balafilcon A toric

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Multi-Center Evaluation Of Two Silicone Hydrogel Toric Contact Lenses

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Lens Orientation [ Time Frame: 1 minute after insertion ] [ Designated as safety issue: No ]
    Proportion of eyes with lens orientation within 5 degrees of optimal

  • Lens Stability [ Time Frame: 10-15 minutes after insertion ] [ Designated as safety issue: No ]
    Lens stability is measured as the amount of rotation induced from blink after the lens has settled.

  • Subjective Comfort [ Time Frame: 2 weeks of lens wear ] [ Designated as safety issue: No ]
    Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5.


Secondary Outcome Measures:
  • Time to Fit Lens [ Time Frame: after lens insertion ] [ Designated as safety issue: No ]
    Time required for the optometrist to fit the lens.

  • Subjective Lens Vision [ Time Frame: measured at 1 and 2 weeks ] [ Designated as safety issue: No ]
    A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.

  • Overall Corneal Staining [ Time Frame: After 2 weeks use ] [ Designated as safety issue: No ]
    National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.


Enrollment: 276
Study Start Date: February 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: senofilcon A toric
senofilcon A, daily wear, toric contact lens worn for two weeks
Device: senofilcon A toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
Other Name: ACUVUE OASYS
Active Comparator: balafilcon A toric
balafilcon A, daily wear, toric contact lens worn for two weeks
Device: balafilcon A toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
Other Name: PureVision Toric

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be between 18 and 45 years of age.
  • Sign Written Informed Consent (See separate document).
  • Be an existing successful daily wear toric soft contact lens.
  • Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).
  • Does not require presbyopic correction (can read J1 @ normal reading distance).
  • Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive)
  • Have refractive astigmatism between 0.75D and 2.50D in both eyes.
  • Achieve visual acuity of 20/30 or better in each eye with spherical distance correction.
  • 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.
    • No conjunctival abnormality or infection.
    • No clinically significant slit lamp findings (i.e. stromal edema, vascularisation, 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 vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
  • Corneal staining Grade 3 in more than one region.
  • 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.
  • Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in the previous 8 weeks
  • Extended lens wear in last 3 months.
  • 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).
  • Pregnancy, lactating or planning a pregnancy at the time of enrolment.
  • Participation in any concurrent clinical trial or in last 60 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638846

  Show 19 Study Locations
Sponsors and Collaborators
Vistakon
Investigators
Study Director: Graeme YOung, MPhil PhD
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00638846     History of Changes
Other Study ID Numbers: CR-0801, CTOR-501
Study First Received: March 10, 2008
Results First Received: June 18, 2010
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vistakon:
toric contact lenses
vision
comfort
toric fit characteristics
slit lamp findings

ClinicalTrials.gov processed this record on April 17, 2014