We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

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.
ClinicalTrials.gov Identifier: NCT01007916
Recruitment Status : Completed
First Posted : November 5, 2009
Results First Posted : February 25, 2011
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.

Condition or disease Intervention/treatment
Myopia Device: Lotrafilcon B contact lens Device: Habitual contact lens

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : October 2009
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Lotrafilcon B / Habitual
Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
Device: Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.
Device: Habitual contact lens
Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
Habitual / Lotrafilcon B
Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
Device: Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.
Device: Habitual contact lens
Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.


Outcome Measures

Primary Outcome Measures :
  1. Comfort Upon Insertion [ Time Frame: 4 weeks of wear ]
    Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.


Eligibility Criteria

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:

  • Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
  • Wears lenses at least 5 days per week and at least 12 hours per day.
  • Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
  • Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
  • Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
  • Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • Currently sleeping in contact lenses for more than 6 consecutive nights.
  • Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
  • Other protocol-defined inclusion/exclusion criteria may apply.
More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01007916     History of Changes
Other Study ID Numbers: P-336-C-016
First Posted: November 5, 2009    Key Record Dates
Results First Posted: February 25, 2011
Last Update Posted: July 10, 2012
Last Verified: January 2012