Visual Performance Investigation of Two Toric Soft Contact Lenses

NCT ID: NCT01858701

Last Updated: 2014-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-10-31

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.

Conditions

Refractive Error; Astigmatism; Myopia; Hyperopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Lotrafilcon B toric contact lens

Intervention Type: DEVICE

Commercially available, silicone hydrogel contact lens for correction of astigmatism

Comfilcon A toric contact lens

Intervention Type: DEVICE

Commercially available, silicone hydrogel contact lens for correction of astigmatism

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.

Group Type: OTHER

Lotrafilcon B toric contact lens

Intervention Type: DEVICE

Commercially available, silicone hydrogel contact lens for correction of astigmatism

Comfilcon A toric contact lens

Intervention Type: DEVICE

Commercially available, silicone hydrogel contact lens for correction of astigmatism

Interventions

Lotrafilcon B toric contact lens

Commercially available, silicone hydrogel contact lens for correction of astigmatism

Intervention Type: DEVICE

Comfilcon A toric contact lens

Commercially available, silicone hydrogel contact lens for correction of astigmatism

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® for ASTIGMATISM; Biofinity® Toric

Eligibility 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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessie Lemp, MS

Role: STUDY_DIRECTOR

Alcon Research

Lyndon Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Optometry and Vision Science

Other Identifiers

P/438/13/L

Identifier Type: -

Identifier Source: secondary_id

A01335

Identifier Type: -

Identifier Source: org_study_id