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Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01268501
First received: December 29, 2010
Last updated: June 26, 2012
Last verified: February 2012

December 29, 2010
June 26, 2012
December 2010
February 2011   (final data collection date for primary outcome measure)
Overall Convenience With Contact Lenses [ Time Frame: 3 weeks of wear ] [ Designated as safety issue: No ]
Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."
Overall Convenience with Contact Lenses [ Time Frame: 3 weeks of wear ] [ Designated as safety issue: No ]
Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3-weeks' wear time. Overall convenience is measured on a 4-point scale, with 1 being Very Satisfied and 4 being Very Dissatisfied.
Complete list of historical versions of study NCT01268501 on ClinicalTrials.gov Archive Site
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Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only
Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes

The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Presbyopia
Device: Lotrafilcon B multifocal contact lens
Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.
Other Name: AIR OPTIX® AQUA MULTIFOCAL
Experimental: Lotrafilcon B multifocal
Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
Intervention: Device: Lotrafilcon B multifocal contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is between 40 and 48 years of age (inclusive).
  • Has read and signed the Informed Consent.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Wears reading spectacles for close work.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks of enrollment.
  • Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions.
  • Currently enrolled in a clinical trial.
  • Has worn contact lenses previously.
  • Other protocol-defined inclusion/exclusion criteria may apply.
Both
40 Years to 48 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01268501
P-319-C-019
No
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Not Provided
Alcon Research
February 2012

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