Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Refractive Errors Clinical Trial

Official title:

Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05431478
• Other study ID #: CLL949-E005
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: September 9, 2022

Study information

• Verified date: September 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Description:

In this crossover study, subjects will wear each study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Best Corrected Visual Acuity of 20/25 Snellen (0.10 logMAR) or better in each eye.
• Willing to stop wearing habitual contact lenses for the duration of study participation.
• 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.
• Habitual wear of AOHP contact lenses.
• Habitual wear of any daily disposable contact lenses.
• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Serafilcon A contact lenses
Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection
• Senofilcon A contact lenses
Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection
• CLEAR CARE
Hydrogen peroxide based contact lens cleaning and disinfecting solution

Locations

Country	Name	City	State
United States	ProCare Vision Center	Granville	Ohio
United States	Drs. Giedd, PA	Maitland	Florida
United States	Wesley Optometric Consulting	Medina	Minnesota
United States	Optometry Group, PLLC	Memphis	Tennessee
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	Visual Acuity With Study Lenses at Week 1 Follow-Up	Visual acuity (VA) was assessed with study lenses in place 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. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint.	Week 1, each wear period. A wear period was approximately 14 days.