Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

Not Applicable

Completed

• Conditions: Refractive Errors; Myopia; Hyperopia
• Interventions: Device: LID015385 contact lenses; Device: Comfilcon A contact lenses; Device: CLEAR CARE

• Registration Number: NCT04207749
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this clinical study is to assess 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 with frequent replacement.

Detailed Description

Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Study Start: 2020-01-22
• Primary Completion: 2020-12-17
• Study Completion: 2020-12-17
• Disposition First Submitted: 2021-12-09
• Status Verified: 2022-01
• Results First Submitted: 2022-01-04
• Results First Submitted QC: 2022-02-01
• Disposition First Submitted QC: 2022-02-01
• Last Update Submitted: 2022-02-01
• Results First Posted: 2022-02-02
• Disposition First Posted: 2022-02-02
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

• Understand and sign an IRB/IEC approved Informed Consent form.
• Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
• Successful wear of frequent replacement, spherical, daily wear 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.
• Best spectacle corrected visual acuity 20/20 or better in each eye.
• Other protocol-defined inclusion criteria may apply.

Key

Exclusion Criteria

• 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 wear.
• Any habitual wear of Biofinity lenses.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LID015385	LID015385 contact lenses	LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.
Biofinity	Comfilcon A contact lenses	Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.
Biofinity	CLEAR CARE	Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.
LID015385	CLEAR CARE	LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)	Week 1 Follow-Up	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 lower logMAR values indicating better visual acuity.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)	Week 1 Follow-Up, at least 4 hours after lens insertion	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, with 20/20 Snellen visual acuity considered normal distance eyesight.

Trial Locations

Locations (18)

Alcon Investigator 8101; 🇺🇸 Brentwood, California, United States

Alcon Investigator 8062; 🇺🇸 Oakland, California, United States

Alcon Investigator 6313; 🇺🇸 Powell, Ohio, United States

Alcon Investigator 6401; 🇺🇸 Warwick, Rhode Island, United States

Alcon Investigator 8108; 🇺🇸 Novato, California, United States

Alcon Investigator 8102; 🇺🇸 Irvine, California, United States

Alcon Investigator 4817; 🇺🇸 Cleveland, Ohio, United States

Alcon Investigator 6567; 🇺🇸 Pittsburg, Kansas, United States

Alcon Investigator 8114; 🇺🇸 Plano, Texas, United States

Alcon Investigator 6353; 🇺🇸 Memphis, Tennessee, United States

Alcon Investigator 8063; 🇺🇸 Brighton, Massachusetts, United States

Alcon Investigator 8103; 🇺🇸 Glendale, Arizona, United States

Alcon Investigator 6565; 🇺🇸 Maitland, Florida, United States

Alcon Investigator 8135; 🇺🇸 Los Angeles, California, United States

Alcon Investigator 8115; 🇺🇸 Norcross, Georgia, United States

Alcon Investigator 8100; 🇺🇸 New York, New York, United States

Alcon Investigator 8109; 🇺🇸 San Francisco, California, United States

Alcon Investigator 6355; 🇺🇸 Orlando, Florida, United States