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

NCT03614130 | Completed Results FDA Device

• 1 other identifier: CLL949-C005
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Refractive Errors

Keywords

Contact Lens; Extended Wear; Overnight 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 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 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/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 approximately 6 nights 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 approximately 6 nights 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 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.

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 (2)

Alcon Investigative Site

Johns Creek, Georgia, 30097, United States

Location

Alcon Investigative Site

Brentwood, Tennessee, 37027, 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: July 30, 2018
• First Posted: August 3, 2018
• Study Start: August 23, 2018
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: September 30, 2021
• Results First Posted: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)