Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Not Applicable

Completed

• Conditions: Refractive Errors
• Interventions: Device: Verofilcon A contact lenses; Device: Etafilcon A contact lenses

• Registration Number: NCT03969290
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-31
• Study Start: 2019-06-05
• Status Verified: 2019-08
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequence 1	Etafilcon A contact lenses	Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.
Sequence 1	Verofilcon A contact lenses	Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.
Sequence 2	Verofilcon A contact lenses	Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.
Sequence 2	Etafilcon A contact lenses	Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Alcon Investigative Site; 🇩🇪 Jena, Germany