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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00762502
First received: September 26, 2008
Last updated: November 18, 2014
Last verified: November 2014

September 26, 2008
November 18, 2014
June 2007
January 2008   (final data collection date for primary outcome measure)
  • Corneal Staining [ Time Frame: at 3 months of lens wear (period 1) ] [ Designated as safety issue: No ]
    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.
  • Limbal Redness [ Time Frame: at 3 months of lens wear (period 1) ] [ Designated as safety issue: No ]
    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.
  • Bulbar Redness [ Time Frame: at 3 months of lens wear (period 1) ] [ Designated as safety issue: No ]
    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.
  • Tarsal Roughness [ Time Frame: at 3 months of lens wear (period 1) ] [ Designated as safety issue: No ]
    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.
conjunctival changes corneal changes superior palpebral changes [ Time Frame: Baseline, 24 hours, 1 week, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00762502 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Corneal Vascularization [ Time Frame: 1-Day of lens wear ] [ Designated as safety issue: No ]
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. For this outcome, analysis is done for investigative purposes only.
Not Provided
 
Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Astigmatism
  • Device: senofilcon A toric contact lens
    soft contact lens
  • Device: balafilcon A toric contact lens
    soft contact lens
  • Active Comparator: senofilcon A toric bilaterally
    senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
    Intervention: Device: senofilcon A toric contact lens
  • Active Comparator: balafilcon A toric bilaterally
    balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
    Intervention: Device: balafilcon A toric 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.
    Interventions:
    • Device: senofilcon A toric contact lens
    • Device: balafilcon A toric contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00762502
CR-4498
No
Vistakon
Vistakon
Not Provided
Not Provided
Vistakon
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP