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Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00697190
First received: June 10, 2008
Last updated: August 29, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention
Astigmatism
 Device: senofilcon A toric
Device: galyfilcon A toric

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.

  • Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) [ Time Frame: after 6 hours of wear ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: May 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: senofilcon A/galyfilcon A
senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.
 Device: senofilcon A toric
silicone hydrogel contact lens for patients with astigmatism
Other Name: Acuvue Oasys for Astigmatism
Device: galyfilcon A toric
silicone hydrogel contact lens for patients with astigmatism
Other Name: Acuvue Advance for Astigmatism
Active Comparator: galyfilcon A/senofilcon A
galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.
 Device: senofilcon A toric
silicone hydrogel contact lens for patients with astigmatism
Other Name: Acuvue Oasys for Astigmatism
Device: galyfilcon A toric
silicone hydrogel contact lens for patients with astigmatism
Other Name: Acuvue Advance for Astigmatism

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697190

Locations
United Kingdom
Eurolens Research
Manchester, United Kingdom
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00697190     History of Changes
Other Study ID Numbers: CR-4523
Study First Received: June 10, 2008
Results First Received: September 9, 2010
Last Updated: August 29, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013