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Completed

NCT Number: NCT00638846

Performance 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.

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Key information

Conditions

Vision Correction

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Camp Eye Care Clinic, North Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

senofilcon A toric

Device

silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)

Other names: ACUVUE OASYS

balafilcon A toric

Device

silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)

Other names: PureVision Toric

Primary outcomes

  1. Lens Orientation

    Time frame: 1 minute after insertion

    Proportion of eyes with lens orientation within 5 degrees of optimal

  2. Lens Stability

    Time frame: 10-15 minutes after insertion

    Lens stability is measured as the amount of rotation induced from blink after the lens has settled.

  3. Subjective Comfort

    Time frame: 2 weeks of lens wear

    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 outcomes

  1. Time to Fit Lens

    Time frame: after lens insertion

    Time required for the optometrist to fit the lens.

  2. Subjective Lens Vision

    Time frame: measured at 1 and 2 weeks

    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.

  3. Overall Corneal Staining

    Time frame: After 2 weeks use

    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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Official study title

Multi-Center Evaluation Of Two Silicone Hydrogel Toric Contact Lenses

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 19, 2008
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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