Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

Not Applicable

Completed

Interventions: Device: Lehfilcon A contact lens
Device: Comfilcon A contact lens

Brief Summary: The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

Detailed Description: Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Recruitment & Eligibility

Inclusion Criteria

Able to understand and sign an IRB/IEC approved Informed Consent form.
Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
Best corrected visual acuity of 20/25 or better in each eye.
Other protocol-specified inclusion criteria may apply.

Key

Exclusion Criteria

Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
Any habitual wear of Biofinity contact lenses.
Pregnant or breast-feeding.
Other protocol specified exclusion criteria may apply.

Arm && Interventions

Group	Intervention	Description
Biofinity (OD) / LID018869 (OS)	Lehfilcon A contact lens	Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
LID018869 (OD) / Biofinity (OS)	Lehfilcon A contact lens	Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
Biofinity (OD) / LID018869 (OS)	Comfilcon A contact lens	Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
LID018869 (OD) / Biofinity (OS)	Comfilcon A contact lens	Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear

Primary Outcome Measures

Name	Time	Method
Distance Visual Acuity (VA) With Study Lenses	Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit	Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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. No formal hypothesis testing was planned.

Secondary Outcome Measures

Name	Time	Method

Locations (3): Alcon Investigator 8046
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Granville, Ohio, United States
Alcon Investigator 6402
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Medina, Minnesota, United States
Alcon Investigator 2786
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Memphis, Tennessee, United States