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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01007916
First received: November 2, 2009
Last updated: June 26, 2012
Last verified: January 2012
  Purpose

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 Intervention
Myopia
Device: Lotrafilcon B contact lens
Device: Habitual contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Comfort Upon Insertion [ Time Frame: 4 weeks of wear ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01007916     History of Changes
Other Study ID Numbers: P-336-C-016
Study First Received: November 2, 2009
Results First Received: January 31, 2011
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 April 15, 2014