Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens

The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Refractive Errors Astigmatism Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sabal Eye Care, Longwood, Florida, United States

About this study

Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Successful wearers of weekly/monthly 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;
Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 Snellen in each eye.
Able to wear contact lenses within the range of available sphere & cylinder power and axes.
Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

Daily disposable contact lens wearers.
Monovision and multifocal contact lens wearers.
Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent.
Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lehfilcon A toric contact lenses

Device

FDA-cleared silicone hydrogel toric contact lenses used as indicated

Other names: LID205255 Toric

Comfilcon A toric contact lenses

Device

Commercially available silicone hydrogel toric contact lenses used as indicated

Other names: Biofinity Toric, CooperVision® Biofinity® Toric

CLEAR CARE

Device

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Primary outcomes

Distance Visual Acuity (VA) With Study Lenses

Time frame: Day 1 and Day 30, each wear period (approximately 30 days)

Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jan 27, 2022
Registry last updated: Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed