Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01858701
First received: May 17, 2013
Last updated: October 17, 2014
Last verified: October 2014
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01858701     History of Changes
Other Study ID Numbers: A01335, P/438/13/L
Study First Received: May 17, 2013
Results First Received: October 17, 2014
Last Updated: October 17, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Alcon Research:
myopia
hyperopia
astigmatism
contact lenses

Additional relevant MeSH terms:
Astigmatism
Hyperopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on November 20, 2014