Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

Not Applicable

Completed

• Conditions: Refractive Errors

• Registration Number: NCT04055519
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Detailed Description

Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Study Start: 2019-09-19
• Primary Completion: 2019-12-03
• Study Completion: 2019-12-03
• Disposition First Submitted: 2020-11-23
• Disposition First Submitted QC: 2020-11-23
• Status Verified: 2021-04
• Results First Submitted: 2021-04-22
• Results First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Results First Posted: 2021-05-13
• Disposition First Posted: 2021-05-13
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Sign Informed Consent document.
• Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Any eye condition or disease or use of medication that contraindicates contact lens wear.
• Eye surgery, irregular cornea, eye injury as specified in the protocol.
• Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
• Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
• Habitually wears Biofinity contact lenses.
• Other protocol-specified exclusion criteria may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Distance VA (logMAR) With Study Lenses	Day 30 after a minimum of 6 hours of wear, each product	Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in 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