Clinical Comparison of Toric Contact Lenses Fit Characteristics

Alcon

Status: Withdrawn

Conditions: Refractive Errors; Astigmatism

Treatments: Device: Delefilcon A toric soft contact lens; Device: Verofilcon A toric soft contact lens; Device: Lotrafilcon B toric soft contact lens; Device: Lehfilcon A toric soft contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT05805345

CLF993-P001

Details and patient eligibility

About

The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 4 patient groups

DT1fA/T30fA/AOHGfA/P1fA

Other group

Description:

DT1fA worn first, followed by T30fA, as randomized, during the first wear period, with AOHGfA worn first, followed by P1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.

Treatment:

Device: Lehfilcon A toric soft contact lens

Device: Lotrafilcon B toric soft contact lens

Device: Verofilcon A toric soft contact lens

Device: Delefilcon A toric soft contact lens

T30fA/AOHGfA/P1fA/DT1fA

Other group

Description:

T30fA worn first, followed by AOHGfA, as randomized, during the first wear period, with P1fA worn first, followed by DT1fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.

Treatment:

Device: Lehfilcon A toric soft contact lens

Device: Lotrafilcon B toric soft contact lens

Device: Verofilcon A toric soft contact lens

Device: Delefilcon A toric soft contact lens

AOHGfA/P1fA/DT1fA/T30fA

Other group

Description:

AOHGfA worn first, followed by P1fA, as randomized, during the first wear period, with DT1fA worn first, followed by T30fA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.

Treatment:

Device: Lehfilcon A toric soft contact lens

Device: Lotrafilcon B toric soft contact lens

Device: Verofilcon A toric soft contact lens

Device: Delefilcon A toric soft contact lens

P1fA/DT1fA/T30fA/AOHGfA

Other group

Description:

P1fA worn first, followed by DT1fA, as randomized, during the first wear period, with T30fA worn first, followed by AOHGfA during the second wear period. Each lens type will be worn in both eyes for approximately 30 minutes. The wear periods will be separated by 1 to 9 days.

Treatment:

Device: Lehfilcon A toric soft contact lens

Device: Lotrafilcon B toric soft contact lens

Device: Verofilcon A toric soft contact lens

Device: Delefilcon A toric soft contact lens