Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980456
• Other study ID #: CLY935-C019
• Status: Completed
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: November 20, 2021

Study information

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

Clinical Trial Summary

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Description:

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: November 20, 2021
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand and sign an approved Informed Consent form;

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

• Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;

• Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;

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

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator;

• Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;

• Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;

• Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;

• Current or prior Biofinity contact lens wear in the past 3 months prior to consent.

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lehfilcon A contact lenses
Investigational silicone hydrogel contact lenses
• Comfilcon A contact lenses
Commercially available silicone hydrogel contact lenses
• CLEAR CARE
Hydrogen peroxide-based cleaning and disinfecting solution

Locations

Country	Name	City	State
United States	Alcon Investigator 8175	Austin	Texas
United States	Alcon Investigator 6356	Longwood	Florida
United States	Alcon Investigator 8135	Los Angeles	California
United States	Alcon Investigator 5582	Louisville	Kentucky
United States	Alcon Investigator 6565	Maitland	Florida
United States	Alcon Investigator 6353	Memphis	Tennessee
United States	Alcon Investigator 8130	New York	New York
United States	Alcon Investigator 8062	Oakland	California
United States	Alcon Investigator 6567	Pittsburg	Kansas
United States	Alcon Investigator 8106	San Francisco	California
United States	Alcon Investigator 8097	Sterling Heights	Michigan
United States	Alcon Investigator 6401	Warwick	Rhode Island
United States	Alcon Investigator 6654	West Palm Beach	Florida
United States	Alcon Investigator 7980	Willmar	Minnesota

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 Distance VA (logMAR) With Study Lenses	Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately 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 study product