Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Errors; Astigmatism
• Interventions: Device: Verofilcon A toric contact lenses; Device: Stenfilcon A toric contact lenses

• Registration Number: NCT05039112
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.

Detailed Description

Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.

Study Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-09
• Study Start: 2021-09-28
• Primary Completion: 2021-11-29
• Study Completion: 2021-11-29
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Successful wear of toric soft 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 study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
• Other protocol-defined inclusion criteria may apply.

Key

Exclusion Criteria

• Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
• Current wear of spherical contact lenses.
• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
P1fA, then MyDay Toric	Verofilcon A toric contact lenses	Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.
MyDay Toric, then P1fA	Stenfilcon A toric contact lenses	Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.
MyDay Toric, then P1fA	Verofilcon A toric contact lenses	Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.
P1fA, then MyDay Toric	Stenfilcon A toric contact lenses	Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.

Primary Outcome Measures

Name	Time	Method
Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion	Day 1, 10 minutes after lens insertion, each product	Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.

Trial Locations

Locations (6)

Alcon Investigator 6565; 🇺🇸 Maitland, Florida, United States

Alcon Investigator 8097; 🇺🇸 Sterling Heights, Michigan, United States

Alcon Investigator 6313; 🇺🇸 Powell, Ohio, United States

Alcon Investigator 6401; 🇺🇸 Warwick, Rhode Island, United States

Alcon Investigator 6353; 🇺🇸 Memphis, Tennessee, United States

Alcon Investigator 6567; 🇺🇸 Pittsburg, Kansas, United States