Clinical Trial of Contact Lenses in Extended Wear

This study has been completed.
Sponsor:
Information provided by:
Vistakon
ClinicalTrials.gov Identifier:
NCT00762502
First received: September 26, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 26, 2008
September 26, 2008
June 2007
January 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Trial of Contact Lenses in Extended Wear
Not Provided

To evaluate the effect of lens properties of the different types of contact lenses on the ocular health of existing contact lens wearers when used in an extended wear modality of up to seven days/six nights.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Astigmatism
  • Device: senofilcon A toric contact lens
    contact lens
  • Device: balafilcon A toric contact lens
    contact lens
  • Active Comparator: 1
    senofilcon A toric
    Intervention: Device: senofilcon A toric contact lens
  • Active Comparator: 2
    balafilcon A toric
    Intervention: Device: balafilcon A toric contact lens
  • Active Comparator: 3
    senofilcon A toric in one eye, balafilcon A toric in the other eye
    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
Not Provided
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) VA OD and OS with study lenses
  • Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 D (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
  • Adapted SCL wearer
  • Swims no more than once a week
  • Has a wearable pair of spectacles.

Exclusion Criteria:

  • Any ocular or systemic disorder which may contraindicate 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
  • PMMA or RGP wear in last 8 weeks
  • Previous AE's that contraindicate EW
  • 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
Australia
 
NCT00762502
CR-4498, JJG0704B3
Not Provided
Dr. John R. Buch / Principal Research Optometrist, Vistakon
Vistakon
Not Provided
Not Provided
Vistakon
September 2008

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