Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

Refractive Ametropia Clinical Trial

Official title:

Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05765227
• Other study ID #: CLN705-M103
• Status: Completed
• Phase: N/A
• Start date: March 8, 2023
• Est. completion date: March 30, 2023

Study information

• Verified date: March 2024
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Description:

Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Key Inclusion Criteria:

• Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
• Willing to stop wearing habitual contact lenses for the duration of study participation;
• Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Any eye infection, inflammation, or 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 plan to have refractive surgery during the study;
• Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
• Monovision contact lens wear;
• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Ametropia
• Refractive Errors

Intervention

Device:
• Lehfilcon A multifocal contact lenses
Investigational silicone hydrogel multifocal contact lenses
• Lotrafilcon B multifocal contact lenses
Commercially available silicone hydrogel multifocal contact lenses
• Hydrogen peroxide-based cleaning and disinfection system
Commercially available cleaning and disinfection system for silicone hydrogel contact lenses

Locations

Country	Name	City	State
United States	Johns Creek Research Clinic	Johns Creek	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular Visual Acuity (VA) With Study Lenses at 4 Meters (logMAR)	VA was assessed binocularly (both eyes together) using a letter chart and measured in 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 hypothesis testing was prespecified for this endpoint.	Day 2, each study lens type worn during the corresponding crossover period