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Completed

NCT Number: NCT00762502

Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Newtown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to wear study lenses in parameters available
  • Non-presbyopes between the ages of 18-45
  • Understand and sign informed consent
  • Willing to follow the protocol
  • Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses
  • Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
  • Adapted soft contact lens wearer
  • Swims no more than once a week
  • Has a wearable pair of spectacles.

Exclusion criteria

  • Any ocular or systemic disorder which may contraindicate contact lens wear
  • Any topical ocular medication
  • Aphakic
  • Corneal refractive surgery
  • Corneal distortion from hard CL wear or keratoconus
  • Pregnant or lactating
  • Grade 2 or worse slit lamp signs
  • Infectious disease
  • Previous clinical study within 2 weeks
  • Don't agree to participate
  • Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks
  • Previous adverse effects that contraindicate extended lens wear.
  • Self-reported symptoms of itchiness or scratchiness with habitual lenses.

Treatment and study plan

senofilcon A toric contact lens

Device

soft contact lens

balafilcon A toric contact lens

Device

soft contact lens

Primary outcomes

  1. Corneal Staining

    Time frame: at 3 months of lens wear (period 1)

    Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

  2. Limbal Redness

    Time frame: at 3 months of lens wear (period 1)

    Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

  3. Bulbar Redness

    Time frame: at 3 months of lens wear (period 1)

    Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

  4. Tarsal Roughness

    Time frame: at 3 months of lens wear (period 1)

    Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 30, 2008
Registry last updated
Jun 19, 2018

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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