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Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00808834
First Posted: December 16, 2008
Last Update Posted: June 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
December 11, 2008
December 16, 2008
June 18, 2010
October 4, 2010
June 29, 2012
November 2008
December 2008   (Final data collection date for primary outcome measure)
Comfort After Insertion [ Time Frame: 30-60 seconds after initial insertion ]
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 ]
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 ]
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 (Participant, 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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00808834
P-335-C-008
No
Not Provided
Not Provided
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