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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
History of Changes
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

Resource links provided by NLM:

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

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


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

Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT00808834     History of Changes
Other Study ID Numbers: P-335-C-008
Study First Received: December 11, 2008
Results First Received: June 18, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013