Clinical Performance of a Silicone Hydrogel Contact Lens Following One Night of Extended Wear

Not Applicable

Completed

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

• Registration Number: NCT03560141
• 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 night 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 4 scheduled study visits. The lenses will be worn continuously from the time of dispense on Day 1 until lens collection at the Day 2 Follow-up/Exit Visit.

Study Timeline

• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-18
• Study Start: 2018-07-11
• Primary Completion: 2018-07-17
• Study Completion: 2018-07-17
• Disposition First Submitted: 2019-07-11
• Disposition First Submitted QC: 2019-07-11
• Status Verified: 2021-07
• Results First Submitted: 2021-07-06
• Results First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Results First Posted: 2021-07-28
• Disposition First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Able to understand and sign an 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 in either a daily wear or extended wear modality.
• 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
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 one night 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 one night of extended (overnight) wear.
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 one night 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 one night of extended (overnight) wear.

Primary Outcome Measures

Name	Time	Method
Visual Acuity (VA) With Study Lenses, Collected by Eye	Day 1 Dispense; Day 1 Follow-up Prior to Sleeping; Day 2 Follow-up Upon Eye Opening; Day 2 Follow-up Approximately 1 Hour after Awakening/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.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Johns Creek, Georgia, United States