Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Not Applicable

Completed

• Conditions: Refractive Error

• Registration Number: NCT03095027
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Study Start: 2017-04-19
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15
• Disposition First Submitted: 2018-05-08
• Disposition First Submitted QC: 2018-05-08
• Status Verified: 2019-01
• Disposition First Posted: 2019-01-04
• Results First Submitted: 2019-01-08
• Results First Submitted QC: 2019-01-08
• Last Update Submitted: 2019-01-08
• Results First Posted: 2019-02-04
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Able to understand and sign an IRB-approved Informed Consent Form;
• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
• Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
• Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
• History of refractive surgery or plan to have refractive surgery during the study;
• Ocular or intraocular surgery within the previous 12 months or planned during the study;
• Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
• Any previous or current wear of MYDAY;
• Habitually wearing monovision or multifocal lenses during the last 3 months;
• Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
• Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Visual Acuity (VA)	Baseline/Dispense (Day 1), Week 1, each product	VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Johns Creek, Georgia, United States