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Visual Performance Investigation of Two Toric Soft Contact Lenses (CARDINAL)

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ClinicalTrials.gov Identifier: NCT01858701
Recruitment Status : Completed
First Posted : May 21, 2013
Results First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):

May 17, 2013
May 21, 2013
October 17, 2014
October 22, 2014
October 22, 2014
May 2013
October 2013   (Final data collection date for primary outcome measure)
Mean Ocular Coma Score at 5mm Pupil at Day 30 [ Time Frame: Day 30 ]
Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.
Mean ocular coma score at Day 30 [ Time Frame: Day 30 ]
Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion.
Complete list of historical versions of study NCT01858701 on ClinicalTrials.gov Archive Site
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Visual Performance Investigation of Two Toric Soft Contact Lenses
Visual Performance Investigation of Two Toric Soft Contact Lenses
The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.
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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Refractive Error
  • Astigmatism
  • Myopia
  • Hyperopia
  • Device: Lotrafilcon B toric contact lens
    Commercially available, silicone hydrogel contact lens for correction of astigmatism
    Other Name: AIR OPTIX® for ASTIGMATISM
  • Device: Comfilcon A toric contact lens
    Commercially available, silicone hydrogel contact lens for correction of astigmatism
    Other Name: Biofinity® Toric
  • AO for Astig / Biofinity Toric
    Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.
    Interventions:
    • Device: Lotrafilcon B toric contact lens
    • Device: Comfilcon A toric contact lens
  • Biofinity Toric / AO for Astig
    Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.
    Interventions:
    • Device: Lotrafilcon B toric contact lens
    • Device: Comfilcon A toric contact lens
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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
49
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Sign informed consent;
  • Wears toric soft contact lenses;
  • Can be successfully fit with study lenses within the power ranges available;
  • Has cylinder of ≥ -0.75 diopter in both eyes;
  • Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses;
  • Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any ocular condition that would contraindicate contact lens wear;
  • Use of medications for which contact lens wear could be contraindicated;
  • Monocular (only 1 eye with functional vision) or fit with 1 lens;
  • History of herpetic keratitis, ocular surgery, or irregular cornea;
  • Known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Requires presbyopic correction;
  • Use of rewetting/lubricating eye-drops more than twice a day;
  • Other protocol-defined exclusion criteria may apply.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada
 
NCT01858701
A01335
P/438/13/L
No
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Alcon Research
Alcon Research
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Study Director: Jessie Lemp, MS Alcon Research
Principal Investigator: Lyndon Jones, PhD School of Optometry and Vision Science
Alcon Research
October 2014

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