Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

NCT03920280 | Completed Results FDA Device

• 1 other identifier: CLL949-C009
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this clinical study is to demonstrate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Conditions

Refractive Errors

Keywords

Contact Lens; Daily Wear; Vision Correction

Outcome Measures

Primary Outcomes (2)

• Distance Visual Acuity (VA) With Study Lenses - Completed Eyes

  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 lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.

  Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit)

• Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes

  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 the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.

  Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)

Study Arms (2)

LID015385

EXPERIMENTAL

LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.

Device: LID015385 contact lenses; Device: CLEAR CARE

Biofinity

ACTIVE COMPARATOR

Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.

Device: Comfilcon A soft contact lenses; Device: CLEAR CARE

Interventions

LID015385 contact lenses DEVICE

Investigational silicone hydrogel contact lenses

LID015385

Comfilcon A soft contact lenses DEVICE

Commercially available silicone hydrogel contact lenses

Also known as: Biofinity

Biofinity

CLEAR CARE DEVICE

Hydrogen peroxide-based cleaning and disinfecting system

Biofinity; LID015385

Eligibility Criteria

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

You may qualify if:

• Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
• Manifest cylinder ≤ 0.75 diopter (D) in each eye.

You may not qualify if:

• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
• Monovision contact lens wearers.
• Habitually wearing Biofinity® lenses.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (8)

Alcon Investigator 6565

Maitland, Florida, 32751, United States

Location

Alcon Investigator 6355

Orlando, Florida, 32803, United States

Location

Alcon Investigator 6291

Pensacola, Florida, 32503, United States

Location

Alcon Investigator 3950

Bloomington, Illinois, 61704, United States

Location

Alcon Investigator 6567

Pittsburg, Kansas, 66762, United States

Location

Alcon Investigator 6313

Powell, Ohio, 43065, United States

Location

Alcon Investigator 6401

Warwick, Rhode Island, 02888, United States

Location

Alcon Investigator 6353

Memphis, Tennessee, 38111, 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 18, 2019
• Study Start: May 22, 2019
• Primary Completion: October 5, 2019
• Study Completion: October 5, 2019
• Last Updated: July 28, 2022
• Results First Posted: February 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)