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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01858701
First Posted: May 21, 2013
Last Update Posted: October 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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 Intervention
Refractive Error Astigmatism Myopia Hyperopia Device: Lotrafilcon B toric contact lens Device: Comfilcon A toric contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Visual Performance Investigation of Two Toric Soft Contact Lenses

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Enrollment: 49
Study Start Date: May 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01858701     History of Changes
Other Study ID Numbers: A01335
P/438/13/L
First Submitted: May 17, 2013
First Posted: May 21, 2013
Results First Submitted: October 17, 2014
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