Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Refractive Error Clinical Trial

Official title:

Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095027
• Other study ID #: CLE383-C003
• Status: Completed
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: May 15, 2017

Study information

• Verified date: January 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• FID122819 contact lenses
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
• Stenfilcon A contact lenses
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Johns Creek	Georgia
United States	Alcon Investigative Site	Longwood	Florida
United States	Alcon Investigative Site	Maitland	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity (VA)	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.	Baseline/Dispense (Day 1), Week 1, each product

External Links

•   Results from the Novartis Clinical Trial Results Website