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Evaluation of Lotrafilcon A Lenses Over a Three Month Period

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00931307
First Posted: July 2, 2009
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 assess the performance of a Lotrafilcon A contact lens over a 3-month period.

Condition Intervention
Myopia Device: Lotrafilcon A contact lens

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Lotrafilcon A Lenses Over a Three Month Period

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Comfort After Insertion [ Time Frame: 3 months ]
    Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 22
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotrafilcon A Device: Lotrafilcon A contact lens
Silicone hydrogel, spherical, soft 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:

  • On examination, have ocular findings considered to be "normal" and which would not prevent a subject 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 inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
  • 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.
  • Any use of medications for which contact lens wear would be contraindicated, in the opinion of the investigator.
  • History of corneal refractive surgery.
  • Other protocol inclusion/exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00931307     History of Changes
Other Study ID Numbers: P-335-C-013
First Submitted: July 1, 2009
First Posted: July 2, 2009
Results First Submitted: September 16, 2010
Results First Posted: October 6, 2010
Last Update Posted: June 29, 2012
Last Verified: October 2010