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Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

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ClinicalTrials.gov Identifier: NCT00808834
Recruitment Status : Completed
First Posted : December 16, 2008
Results First Posted : October 4, 2010
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

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

Condition or disease Intervention/treatment Phase
Myopia Device: Lotrafilcon A contact lens Device: Senofilcon A contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
Study Start Date : November 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Senofilcon A / Lotrafilcon A
Senofilcon A, followed by Lotrafilcon A
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
Lotrafilcon A / Senofilcon A
Lotrafilcon A, followed by Senofilcon A
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00808834     History of Changes
Other Study ID Numbers: P-335-C-008
First Posted: December 16, 2008    Key Record Dates
Results First Posted: October 4, 2010
Last Update Posted: June 29, 2012
Last Verified: January 2012