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

October 17, 2014 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • AIR OPTIX® for ASTIGMATISM
Device: Comfilcon A toric contact lens
Commercially available, silicone hydrogel contact lens for correction of astigmatism
Other Names:
  • Biofinity® Toric
Other: 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 Names:
  • AIR OPTIX® for ASTIGMATISM
Device: Comfilcon A toric contact lens
Commercially available, silicone hydrogel contact lens for correction of astigmatism
Other Names:
  • Biofinity® Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Principal Investigator: Lyndon Jones, PhD, School of Optometry and Vision Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 21, 2013

Study Record Updates

Last Update Posted (Estimate)

October 22, 2014

Last Update Submitted That Met QC Criteria

October 17, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A01335
  • P/438/13/L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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