Clinical Comparison of Toric Contact Lenses Fit Characteristics

Astigmatism Clinical Trial

Official title:

Clinical Comparison of Toric Contact Lenses Fit Characteristics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05805345
• Other study ID #: CLF993-P001
• Status: Withdrawn
• Phase: N/A
• Start date: April 2023
• Est. completion date: May 2023

Study information

• Verified date: May 2023
• 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 fit characteristics between four Alcon commercially available toric contact lenses.

Description:

Subjects will be expected to attend 3 visits including the screening visit. The total duration of a subject's participation in the study will be approximately 19 days.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• 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.
• Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability).
• Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye.
• Willing to stop wearing habitual contact lenses during in-office visits.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current spherical, monovision or multifocal lens wearer.
• Protocol-specified biomicroscopy findings at screening.
• Current or history of herpetic keratitis in either eye.
• Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Astigmatism
• Refractive Errors

Intervention

Device:
• Delefilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
• Lehfilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens
• Lotrafilcon B toric soft contact lens
Commercially available silicone hydrogel contact lens
• Verofilcon A toric soft contact lens
Commercially available silicone hydrogel contact lens

Locations

Country	Name	City	State
United States	ProCare Vision Centers, Inc.	Granville	Ohio
United States	Omega Vision Center P.A.	Longwood	Florida
United States	Kurata Eyecare Center	Los Angeles	California
United States	Kindred Optics at Maitland Vision	Maitland	Florida
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Kannarr Eye Care LLC	Pittsburg	Kansas
United States	Clarke EyeCare Center	Wichita Falls	Texas

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 VA with study lenses	Visual Acuity (VA) will be assessed using letter charts with study lenses in place and reported in logarithm minimum angle of resolution (logMAR). A logMAR value of 0.0 equates to 20/20 Snellen, which is considered normal distance eyesight. Eyes will be assessed individually.	30 mins (± 15 mins), each product