Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Refractive Errors Clinical Trial

Official title:

Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969290
• Other study ID #: CLE383-P001
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: August 5, 2019

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

Description:

The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand and sign an approved Informed Consent form

• Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day

• Best corrected VA of logMAR 0.10 or better in each eye

• Willing to discontinue artificial tears and rewetting drops during the study

• Able to wear contact lenses within the protocol-specified sphere power range

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, or abnormality or disease 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 ocular or intraocular surgery, including refractive surgery, and/or irregular cornea

• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment

• Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Verofilcon A contact lenses
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
• Etafilcon A contact lenses
Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Locations

Country	Name	City	State
Germany	Alcon Investigative Site	Jena

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of day (EOD) visual acuity at distance	Visual acuity (VA) will be measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity.	Day 1, after 8 hours of wear