Evaluation of Lotrafilcon A Lenses Over a Three Month Period

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00931307
First received: July 1, 2009
Last updated: June 26, 2012
Last verified: October 2010
  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: 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:

Primary Outcome Measures:
  • Comfort After Insertion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

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 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

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT00931307     History of Changes
Other Study ID Numbers: P-335-C-013
Study First Received: July 1, 2009
Results First Received: September 16, 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 April 23, 2014