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Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

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ClinicalTrials.gov Identifier: NCT00697190
Recruitment Status : Completed
First Posted : June 13, 2008
Results First Posted : October 1, 2010
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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

Condition or disease Intervention/treatment Phase
Astigmatism Device: senofilcon A toric Device: galyfilcon A toric Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : May 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697190


Locations
United Kingdom
Eurolens Research
Manchester, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00697190     History of Changes
Other Study ID Numbers: CR-4523
First Posted: June 13, 2008    Key Record Dates
Results First Posted: October 1, 2010
Last Update Posted: May 22, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases