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

Condition Intervention
Myopia Device: Lotrafilcon A contact lens Device: Senofilcon A contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

Resource links provided by NLM:


Further study details as provided by Alcon Research ( CIBA VISION ):

Primary Outcome Measures:
  • 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.


Enrollment: 196
Study Start Date: November 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00808834     History of Changes
Other Study ID Numbers: P-335-C-008
First Submitted: December 11, 2008
First Posted: December 16, 2008
Results First Submitted: June 18, 2010
Results First Posted: October 4, 2010
Last Update Posted: June 29, 2012
Last Verified: January 2012