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

NCT03560141 | Completed Results FDA Device

• 1 other identifier: CLL949-C004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Errors

Keywords

Contact Lens; Extended Wear; Contralateral Wear; Vision Correction

Outcome Measures

Primary Outcomes (1)

• Visual Acuity (VA) With Study Lenses, Collected by Eye

  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.

  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

Study Arms (2)

LID011121 (OD) / Biofinity (OS)

OTHER

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.

Device: LID011121 contact lens; Device: Comfilcon A contact lens

Biofinity (OD) / LID011121 (OS)

OTHER

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.

Device: LID011121 contact lens; Device: Comfilcon A contact lens

Interventions

LID011121 contact lens DEVICE

Investigational silicone hydrogel contact lens

Biofinity (OD) / LID011121 (OS); LID011121 (OD) / Biofinity (OS)

Comfilcon A contact lens DEVICE

Commercially available silicone hydrogel contact lens

Also known as: Biofinity

Biofinity (OD) / LID011121 (OS); LID011121 (OD) / Biofinity (OS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Investigative Site

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: CDMA Project Lead, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• CDMA Project Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 18, 2018
• Study Start: July 11, 2018
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: July 28, 2021
• Results First Posted: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)