Visual Performance Investigation of Two Toric Soft Contact Lenses

NCT01858701 | Completed Results

• 2 other identifiers: A01335P/438/13/L
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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

Keywords

myopia; hyperopia; astigmatism; contact lenses

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

AO for Astig / Biofinity Toric

OTHER

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; Device: Comfilcon A toric contact lens

Biofinity Toric / AO for Astig

OTHER

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; Device: Comfilcon A toric contact lens

Interventions

Lotrafilcon B toric contact lens DEVICE

Commercially available, silicone hydrogel contact lens for correction of astigmatism

Also known as: AIR OPTIX® for ASTIGMATISM

AO for Astig / Biofinity Toric; Biofinity Toric / AO for Astig

Comfilcon A toric contact lens DEVICE

Commercially available, silicone hydrogel contact lens for correction of astigmatism

Also known as: Biofinity® Toric

AO for Astig / Biofinity Toric; Biofinity Toric / AO for Astig

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors; Astigmatism; Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Jessie Lemp, GMA Brand Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Jessie Lemp, MS

  Alcon Research

  STUDY DIRECTOR

• Lyndon Jones, PhD

  School of Optometry and Vision Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 22, 2014
• Results First Posted: October 22, 2014

Record last verified: 2014-10