Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00808834
First received: December 11, 2008
Last updated: June 26, 2012
Last verified: January 2012

December 11, 2008
June 26, 2012
November 2008
December 2008   (final data collection date for primary outcome measure)
Comfort After Insertion [ Time Frame: 30-60 seconds after initial insertion ] [ Designated as safety issue: No ]
Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.
Measure: The trial objective is to obtain subjective responses related to comfort and handling, and lens surface variables during 15 minutes wear of lotrafilcon A upgrade lenses, and to compare these to responses from senofilcon A lens wear. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00808834 on ClinicalTrials.gov Archive Site
Not Provided
Ease of removal and lens surface characteristics [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Myopia
  • Device: Lotrafilcon A contact lens
    Investigational, silicone hydrogel, spherical, soft contact lens
  • Device: Senofilcon A contact lens
    Commercially marketed, silicone hydrogel, spherical, soft contact lens
  • Senofilcon A / Lotrafilcon A
    Senofilcon A, followed by Lotrafilcon A
    Interventions:
    • Device: Lotrafilcon A contact lens
    • Device: Senofilcon A contact lens
  • Lotrafilcon A / Senofilcon A
    Lotrafilcon A, followed by Senofilcon A
    Interventions:
    • Device: Lotrafilcon A contact lens
    • Device: Senofilcon A 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
196
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently wearing soft contact lenses
  • Replaces lenses on a weekly or longer schedule
  • Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

  • Requires concurrent ocular medication
  • Eye injury or surgery within twelve weeks immediately prior to enrollment
  • Currently wearing soft toric lens wearers
  • Those who dispose of their soft lenses on a daily basis
  • Other protocol-defined inclusion/exclusion criteria may apply
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00808834
P-335-C-008
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