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Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

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ClinicalTrials.gov Identifier: NCT00810511
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : October 1, 2010
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.

Condition or disease Intervention/treatment
Myopia Device: Lotrafilcon A contact lens Device: Comfilcon A contact lens

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
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
Study Start Date : November 2008
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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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
More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00810511     History of Changes
Other Study ID Numbers: P-335-C-007
First Posted: December 18, 2008    Key Record Dates
Results First Posted: October 1, 2010
Last Update Posted: June 29, 2012
Last Verified: January 2012