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Completed

NCT Number: NCT00697190

Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research

Manchester, United Kingdom

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.
  • At least 18
  • understand and sign informed consent
  • willing to follow the protocol
  • achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses
  • hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180
  • oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months

Exclusion criteria

  • Any ocular or systemic disorder which may contraindicate Contact Lens (CL) 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

Treatment and study plan

senofilcon A toric

Device

silicone hydrogel contact lens for patients with astigmatism

Other names: Acuvue Oasys for Astigmatism

galyfilcon A toric

Device

silicone hydrogel contact lens for patients with astigmatism

Other names: Acuvue Advance for Astigmatism

Primary outcomes

  1. Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)

    Time frame: after 6 hours of wear

    Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  2. Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)

    Time frame: after 6 hours of wear

    Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  3. Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)

    Time frame: after 6 hours of wear

    Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  4. Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)

    Time frame: after 6 hours of wear

    Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  5. Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)

    Time frame: after 6 hours of wear

    Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  6. Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)

    Time frame: after 6 hours of wear

    Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  7. Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)

    Time frame: after 6 hours of wear

    Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  8. Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)

    Time frame: after 6 hours of wear

    Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  9. Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)

    Time frame: after 6 hours of wear

    Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  10. Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)

    Time frame: after 6 hours of wear

    Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  11. Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)

    Time frame: after 6 hours of wear

    Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  12. Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)

    Time frame: after 6 hours of wear

    Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  13. Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)

    Time frame: after 6 hours of wear

    Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  14. Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)

    Time frame: after 6 hours of wear

    Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

  15. Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)

    Time frame: after 6 hours of wear

    Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 13, 2008
Registry last updated
May 22, 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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