Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses

Not Applicable

Completed

Interventions: Device: LID220365 contact lens
Device: LID006961 contact lens

Brief Summary: The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.

Detailed Description: The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.

Recruitment & Eligibility

Inclusion Criteria

Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
Other protocol-specified inclusion criteria may apply.

Key

Exclusion Criteria

Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
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.
Habitual monovision or multifocal contact lens wearers.
Other protocol-specified exclusion criteria may apply.

Arm && Interventions

Group	Intervention	Description
LID006961 (OD) / LID220365 (OS)	LID220365 contact lens	LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.
LID220365 (OD) / LID006961 (OS)	LID220365 contact lens	LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.
LID220365 (OD) / LID006961 (OS)	LID006961 contact lens	LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.
LID006961 (OD) / LID220365 (OS)	LID006961 contact lens	LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4	Day 4	VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Secondary Outcome Measures

Name	Time	Method

Locations (7): Kindred Optics at Maitland Vision
🇺🇸
Maitland, Florida, United States
SUNY College of Optometry Clinical Vision Research Center
🇺🇸
New York, New York, United States
Clarke Eyecare Center
🇺🇸
Wichita Falls, Texas, United States
Optometry Group, PLLC
🇺🇸
Memphis, Tennessee, United States
Vision Health Institute
🇺🇸
Orlando, Florida, United States
Franklin Park Eye Center PC
🇺🇸
Franklin Park, Illinois, United States
Wyomissing Optometric Center
🇺🇸
Wyomissing, Pennsylvania, United States