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Clinical Evaluation of a Silicone Hydrogel Lens

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ClinicalTrials.gov Identifier: NCT01016132
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : January 12, 2011
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.

Condition or disease Intervention/treatment
Myopia Device: lotrafilcon A contact lens

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

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.
More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01016132     History of Changes
Other Study ID Numbers: P-019-C-055
First Posted: November 18, 2009    Key Record Dates
Results First Posted: January 12, 2011
Last Update Posted: June 29, 2012
Last Verified: September 2011