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: December 3, 2014
Last verified: December 2014
  Purpose

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 Intervention
Astigmatism
Device: senofilcon A toric contact lens
Device: balafilcon A toric contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • 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.


Enrollment: 112
Study Start Date: June 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.
  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: 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
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00762502     History of Changes
Other Study ID Numbers: CR-4498
Study First Received: September 26, 2008
Results First Received: March 28, 2014
Last Updated: December 3, 2014
Health Authority: Australia: Human Research Ethics Committee

ClinicalTrials.gov processed this record on March 26, 2015