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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):
Alcon Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Refractive Error Astigmatism Myopia Hyperopia Device: Lotrafilcon B toric contact lens Device: Comfilcon A toric contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Visual Performance Investigation of Two Toric Soft Contact Lenses
Study Start Date : May 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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.
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
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.
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858701


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jessie Lemp, MS Alcon Research
Principal Investigator: Lyndon Jones, PhD School of Optometry and Vision Science

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01858701     History of Changes
Other Study ID Numbers: A01335
P/438/13/L
First Posted: May 21, 2013    Key Record Dates
Results First Posted: October 22, 2014
Last Update Posted: October 22, 2014
Last Verified: October 2014

Keywords provided by Alcon Research:
myopia
hyperopia
astigmatism
contact lenses

Additional relevant MeSH terms:
Myopia
Astigmatism
Refractive Errors
Hyperopia
Eye Diseases