Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

Refractive Errors Clinical Trial

Official title:

Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532099
• Other study ID #: CLY935-C020
• Status: Completed
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: May 2021
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).

Description:

Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits. Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Sign an approved Informed Consent Form.
• Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Any eye condition or use of medication that contraindicates contact lens wear, 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, in the opinion of the Investigator, would preclude contact lens wear.
• Routinely sleeps in contact lenses at least 1 night per week.
• Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
• Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).
• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• Lehfilcon A contact lenses
Investigational soft contact lenses for daily wear worn in Part A of the study
• Senofilcon A contact lenses
Commercially available soft contact lenses for daily wear worn in Part A of the study
• Comfilcon A contact lenses
Commercially available soft contact lenses for daily wear worn in Part B of the study
• Hydrogen peroxide-based cleaning and disinfecting solution
For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study

Locations

Country	Name	City	State
United States	Alcon Investigator 6356	Longwood	Florida
United States	Alcon Investigator 6565	Maitland	Florida
United States	Alcon Investigator 6353	Memphis	Tennessee
United States	Alcon Investigator 6401	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	Distance Visual Acuity (VA) (Part A)	Distance 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.	Day 30, each study lens type