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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: October 28, 2014
Last verified: October 2014
  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
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: 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: October 28, 2014
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 November 25, 2014