Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

Astigmatism Clinical Trial

Official title:

Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039112
• Other study ID #: CLA306-E001
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: November 29, 2021

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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.

Related Conditions & MeSH terms

• Astigmatism
• Refractive Errors

Intervention

Device:
• Verofilcon A toric contact lenses
Soft contact lenses for optical correction of astigmatism, used as indicated
• Stenfilcon A toric contact lenses
Soft contact lenses for optical correction of astigmatism, used as indicated

Locations

Country	Name	City	State
United States	Alcon Investigator 6565	Maitland	Florida
United States	Alcon Investigator 6353	Memphis	Tennessee
United States	Alcon Investigator 6567	Pittsburg	Kansas
United States	Alcon Investigator 6313	Powell	Ohio
United States	Alcon Investigator 8097	Sterling Heights	Michigan
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	Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion	Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.	Day 1, 10 minutes after lens insertion, each product