Performance of Two Silicone Hydrogel Toric Contact Lenses

Multi-Center Evaluation Of Two Silicone Hydrogel Toric Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Vision Correction
• Intervention / Treatment: Device: senofilcon A toric; Device: balafilcon A toric

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72116
      • Camp Eye Care Clinic
  • California
    • Mission Viejo, California, United States, 92691
      • James R. Dugue, O.D.
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Executive Park Eye Care
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Dr. Ted Brink and Associates
  • Kansas
    • Neodesha, Kansas, United States, 66757
      • Grene Vision Group
  • Missouri
    • Raytown, Missouri, United States, 64133
      • Advanced Eyecare, PC
  • New Jersey
    • Florence, New Jersey, United States, 08518
      • Dr. James Brobst
  • New York
    • Rochester, New York, United States, 14623
      • Fine Eye Care Associates
  • Ohio
    • Warren, Ohio, United States, 44484
      • Warren Ophthalmology Associates
  • Pennsylvania
    • Kittanning, Pennsylvania, United States, 16201
      • Selden Eyecare LLC
    • State College, Pennsylvania, United States, 16801
      • Nittany Eye Associates
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Dr. David W. Ferris and Associates
  • South Dakota
    • Chamberlain, South Dakota, United States, 57325-0490
      • Dr. Larry Menning
  • Texas
    • Katy, Texas, United States, 77450
      • Wishnow-Sugar Vision Group
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Dr. William Bogus
  • Virginia
    • Midlothian, Virginia, United States, 23113
      • Midlothian Optometric Center
    • Virginia Beach, Virginia, United States, 23455
      • The Eye Specialists, Ltd.
  • Washington
    • Bremerton, Washington, United States, 98310
      • The Eye & Contact Lens Clinic
  • Wisconsin
    • Franklin, Wisconsin, United States, 53132
      • Matus Eyecare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: PureVision Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Orientation	Proportion of eyes with lens orientation within 5 degrees of optimal	1 minute after insertion
Lens Stability	Lens stability is measured as the amount of rotation induced from blink after the lens has settled.	10-15 minutes after insertion
Subjective Comfort	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.	2 weeks of lens wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Fit Lens	Time required for the optometrist to fit the lens.	after lens insertion
Subjective Lens Vision	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.	measured at 1 and 2 weeks
Overall Corneal Staining	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.	After 2 weeks use

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Graeme YOung, MPhil PhD

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: March 10, 2008
• First Submitted That Met QC Criteria: March 10, 2008
• First Posted (Estimate): March 19, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: comfort; vision; toric contact lenses; toric fit characteristics; slit lamp findings
• Other Study ID Numbers: CR-0801; CTOR-501