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Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00810511
First Posted: December 18, 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 trial is to compare two different contact lenses during 4 weeks of wear.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Comfort at End of Day [ Time Frame: After 4 weeks of wear ]
    Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 213
Study Start Date: November 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotrafilcon A
Investigational, spherical, silicone hydrogel contact lenses
Device: Lotrafilcon A contact lens
Silicone hydrogel contact lens
Active Comparator: Comfilcon A
Commercially marketed, spherical, silicone hydrogel contact lenses
Device: Comfilcon A contact lens
Silicone hydrogel 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:

  • Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
  • Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
  • Replace lenses on a weekly or longer schedule
  • Other protocol inclusion/exclusion criteria may apply

Exclusion Criteria:

  • Requires concurrent ocular medication
  • Eye injury or surgery within twelve weeks immediately prior to enrollment
  • Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
  • Current soft toric lens wearers
  • Those who dispose of their soft lenses on a daily basis
  • Current NIGHT & DAY® or Biofinity® lens wearers
  • 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: NCT00810511     History of Changes
Other Study ID Numbers: P-335-C-007
First Submitted: December 17, 2008
First Posted: December 18, 2008
Results First Submitted: July 23, 2010
Results First Posted: October 1, 2010
Last Update Posted: June 29, 2012
Last Verified: January 2012