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, 2013
Last verified: August 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014