Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

Not Applicable

Completed

• Conditions: Refractive Errors

• Registration Number: NCT04178720
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Detailed Description

Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Study Start: 2020-01-28
• Primary Completion: 2020-06-10
• Study Completion: 2020-06-10
• Results First Submitted: 2021-04-22
• Results First Submitted QC: 2021-05-12
• Results First Posted: 2021-05-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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 equal to or less than 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.
• Habitually wearing Biofinity contact lenses.
• Monovision contact lens wearers.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Distance VA (logMAR) With Study Lenses - Completed Eyes	Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 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 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.
Distance VA (logMAR) With Study Lenses - Discontinued Eyes	Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up	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.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Memphis, Tennessee, United States