Visual Performance Investigation of Two Toric Soft Contact Lenses

Myopia Clinical Trial

— CARDINAL  

Official title:

Visual Performance Investigation of Two Toric Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858701
• Other study ID #: A01335
• Secondary ID: P/438/13/L
• Status: Completed
• Phase: N/A
• First received: May 17, 2013
• Last updated: October 17, 2014
• Start date: May 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Hyperopia
• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Lotrafilcon B toric contact lens
Commercially available, silicone hydrogel contact lens for correction of astigmatism
• Comfilcon A toric contact lens
Commercially available, silicone hydrogel contact lens for correction of astigmatism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Ocular Coma Score at 5mm Pupil at 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	No