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
  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:


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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014