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Clinical Evaluation of a Silicone Hydrogel Lens

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016132
First Posted: November 18, 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 study is to assess the performance of an investigational contact lens among contact lens wearers.

Condition Intervention
Myopia Device: lotrafilcon A contact lens

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall Preference [ Time Frame: 4 weeks of wear ]
    Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.


Enrollment: 152
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: lotrafilcon A contact lens
    Investigational silicone hydrogel, single-vision, soft contact lens worn for four weeks at least as often as and on the same basis as participant's habitual lenses, as prescribed by participant's eye care practitioner -- ie., on a daily wear, flex wear, or extended wear basis.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
  • Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
  • Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
  • Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within 12 months prior to enrollment.
  • Currently enrolled in any clinical trial.
  • 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: NCT01016132     History of Changes
Other Study ID Numbers: P-019-C-055
First Submitted: November 17, 2009
First Posted: November 18, 2009
Results First Submitted: December 17, 2010
Results First Posted: January 12, 2011
Last Update Posted: June 29, 2012
Last Verified: September 2011