Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear

Not Applicable

Completed

• Conditions: Refractive Errors
• Interventions: Device: LID011121 contact lens; Device: Comfilcon A contact lens

• Registration Number: NCT03614130
• Lead Sponsor: Alcon Research

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 following 1 week of extended wear.

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 Baseline/Dispense; Day 2 Follow-up; 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.

Study Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Study Start: 2018-08-23
• Primary Completion: 2018-09-11
• Study Completion: 2018-09-11
• Disposition First Submitted: 2019-09-09
• Disposition First Submitted QC: 2019-09-09
• Status Verified: 2021-09
• Results First Submitted: 2021-09-02
• Results First Submitted QC: 2021-09-02
• Last Update Submitted: 2021-09-02
• Results First Posted: 2021-09-30
• Disposition First Posted: 2021-09-30
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Able to understand and sign an Institutional Review Board/Ethics Committee-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 per week and in an extended wear modality a minimum of 1 night per week.
• Best Corrected Visual Acuity (BCVA) 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.
• Current Biofinity© lens wearer.
• Pregnant or breast-feeding.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biofinity (OD) / LID011121 (OS)	LID011121 contact lens	Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
Biofinity (OD) / LID011121 (OS)	Comfilcon A contact lens	Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
LID011121 (OD) / Biofinity (OS)	Comfilcon A contact lens	LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
LID011121 (OD) / Biofinity (OS)	LID011121 contact lens	LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear

Primary Outcome Measures

Name	Time	Method
Visual Acuity (VA) With Study Lenses, Collected by Eye	Day 1 Dispense; Day 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/Exit	Visual acuity (VA) was assessed for each eye individually with study lenses in place 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.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Brentwood, Tennessee, United States