Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00933166
First received: July 2, 2009
Last updated: June 26, 2012
Last verified: January 2012
  Purpose

The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.


Condition Intervention
Myopia
Device: Lotrafilcon A contact lens

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Comfort After Insertion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 169
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotrafilcon A
Investigational contact lens worn in both eyes for three months
Device: Lotrafilcon A contact lens
Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
  • Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
  • Be able to wear the study lenses in the available powers.
  • Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks of enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in an ophthalmic clinical trial.
  • Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • History of corneal refractive surgery.
  • 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: NCT00933166     History of Changes
Other Study ID Numbers: P-335-C-014v2
Study First Received: July 2, 2009
Results First Received: December 2, 2010
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 August 01, 2014