Visual Performance Investigation of Two Toric Soft Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Error; Myopia; Astigmatism; Hyperopia
• Interventions: Device: Lotrafilcon B toric contact lens; Device: Comfilcon A toric contact lens

• Registration Number: NCT01858701
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-21
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Results First Submitted: 2014-10-17
• Results First Submitted QC: 2014-10-17
• Last Update Submitted: 2014-10-17
• Results First Posted: 2014-10-22
• Last Update Posted: 2014-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AO for Astig / Biofinity Toric	Lotrafilcon B toric contact lens	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.
Biofinity Toric / AO for Astig	Lotrafilcon B toric contact lens	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.
AO for Astig / Biofinity Toric	Comfilcon A toric contact lens	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.
Biofinity Toric / AO for Astig	Comfilcon A toric contact lens	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.

Primary Outcome Measures

Name	Time	Method
Mean Ocular Coma Score at 5mm Pupil at Day 30	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.