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Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01007916
First received: November 2, 2009
Last updated: June 26, 2012
Last verified: January 2012

November 2, 2009
June 26, 2012
October 2009
January 2010   (final data collection date for primary outcome measure)
Comfort Upon Insertion [ Time Frame: 4 weeks of wear ] [ Designated as safety issue: No ]
Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.
comfortable wear time [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01007916 on ClinicalTrials.gov Archive Site
Not Provided
subjective ratings and preferences for overall vision and consistent vision. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population
Not Provided

The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Myopia
  • Device: Lotrafilcon B contact lens
    Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.
  • Device: Habitual contact lens
    Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
  • Lotrafilcon B / Habitual
    Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
    Interventions:
    • Device: Lotrafilcon B contact lens
    • Device: Habitual contact lens
  • Habitual / Lotrafilcon B
    Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
    Interventions:
    • Device: Lotrafilcon B contact lens
    • Device: Habitual 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
50
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
  • Wears lenses at least 5 days per week and at least 12 hours per day.
  • Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
  • Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
  • Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
  • Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • Currently sleeping in contact lenses for more than 6 consecutive nights.
  • Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
  • Other protocol-defined inclusion/exclusion criteria may apply.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
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NCT01007916
P-336-C-016
No
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Not Provided
Alcon Research
January 2012

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