Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

Not Applicable

Completed

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

• Registration Number: NCT03920280
• Lead Sponsor: Alcon Research

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.

Detailed Description

Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-18
• Study Start: 2019-05-22
• Primary Completion: 2019-10-05
• Study Completion: 2019-10-05
• Disposition First Submitted: 2020-10-01
• Disposition First Submitted QC: 2020-10-01
• Results First Submitted: 2022-01-04
• Results First Submitted QC: 2022-01-04
• Results First Posted: 2022-02-01
• Disposition First Posted: 2022-02-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.
• Other protocol-specified 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 wearers.
• Habitually wearing Biofinity® lenses.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofinity	Comfilcon A soft contact lenses	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.
Biofinity	CLEAR CARE	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.
LID015385	LID015385 contact lenses	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.
LID015385	CLEAR CARE	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.

Primary Outcome Measures

Name	Time	Method
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes	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)	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.
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes	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)	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.

Trial Locations

Locations (8)

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

Alcon Investigator 3950; 🇺🇸 Bloomington, Illinois, United States

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

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

Alcon Investigator 6291; 🇺🇸 Pensacola, Florida, United States

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

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

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