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OpenTrials
Completed

NCT Number: NCT01858701

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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Key information

Conditions

Refractive Error Astigmatism Eye Diseases Hyperopia Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon B toric contact lens

Device

Commercially available, silicone hydrogel contact lens for correction of astigmatism

Other names: AIR OPTIX® for ASTIGMATISM

Comfilcon A toric contact lens

Device

Commercially available, silicone hydrogel contact lens for correction of astigmatism

Other names: Biofinity® Toric

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Acronym: CARDINAL

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 21, 2013
Registry last updated
Oct 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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