Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Presbyopia Clinical Trial

Official title:

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338333
• Other study ID #: CLN705-C001
• Status: Completed
• Phase: N/A
• Start date: May 27, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.

Description:

Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Key Inclusion Criteria:

• Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.

• Willing and able to attend all study visits as required by the protocol.

• Willing to stop wearing habitual contact lenses for the duration of the study.

• Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.

• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.

• History of refractive surgery or planning to have refractive surgery during the study.

• Current or history of pathologically dry eye.

• Currently pregnant or lactating.

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Lehfilcon A multifocal contact lenses
Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia
• Lotrafilcon B multifocal contact lenses
Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia
• CLEAR CARE®
Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Locations

Country	Name	City	State
United States	The Eye Doctors, Inc.	Eden Prairie	Minnesota
United States	ProCare Vision Centers, Inc.	Granville	Ohio
United States	Kindred Optics at Maitland Vision	Maitland	Florida
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Vision Health Institute	Orlando	Florida
United States	Kannarr Eye Care LLC	Pittsburg	Kansas
United States	West Bay Eye Associates	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses	Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.	Day 30, each wear period. A wear period was approximately 30 days.