Clinical Evaluation of a Silicone Hydrogel Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01016132
First received: November 17, 2009
Last updated: June 26, 2012
Last verified: September 2011

November 17, 2009
June 26, 2012
October 2009
December 2009   (final data collection date for primary outcome measure)
Overall Preference [ Time Frame: 4 weeks of wear ] [ Designated as safety issue: No ]
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.
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Complete list of historical versions of study NCT01016132 on ClinicalTrials.gov Archive Site
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Clinical Evaluation of a Silicone Hydrogel Lens
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The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.

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Interventional
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Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Myopia
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01016132
P-019-C-055
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Alcon Research ( CIBA VISION )
CIBA VISION
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Alcon Research
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP