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

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ClinicalTrials.gov Identifier: NCT00762502
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : November 25, 2014
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Astigmatism Device: senofilcon A toric contact lens Device: balafilcon A toric contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Study Start Date : June 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 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 toric bilaterally
senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
Device: senofilcon A toric contact lens
soft contact lens
Active Comparator: balafilcon A toric bilaterally
balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
Device: balafilcon A toric contact lens
soft contact lens
Active Comparator: senofilcon A/balafilcon A contralaterally
senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
Device: senofilcon A toric contact lens
soft contact lens
Device: balafilcon A toric contact lens
soft contact lens



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT00762502


Locations
United States, Massachusetts
Boston, Massachusetts, United States, 021115
Australia, New South Wales
Newtown, New South Wales, Australia, 2042
Australia, Victoria
Camberwell, Victoria, Australia, 3124
Hawthorn, Victoria, Australia, 3122
Keilor, Victoria, Australia, 3036
Melbourne, Victoria, Australia, 3000
Mitcham, Victoria, Australia, 3132
Moe, Victoria, Australia, 3825
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00762502     History of Changes
Other Study ID Numbers: CR-4498
First Posted: September 30, 2008    Key Record Dates
Results First Posted: November 25, 2014
Last Update Posted: May 22, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases