Clinical trial NCT05483127: Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses
Official title: Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Ametropia
Myopia
Keywords: Contact lenses
Vision
Eye sight
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2022-08-01
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).

Detailed description: Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.

Eligibility criteria: Key Inclusion Criteria:

* Successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Able to wear contact lenses within a range of sphere \& cylinder power and axes.
* Willing to NOT use rewetting/lubricating drops at any time during the study.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current or previous P1fA and MDT habitual lens wearers.
* Monovision and multifocal lens wearers.
* Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Means Distance Visual Acuity With Study Lenses at Week 1
timeFrame: Day 8 of each study lens type worn during the corresponding crossover period
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kurata Eyecare Center
state: California
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Maitland
country: United States
facility: Drs. Giedd, P.A.
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Franklin Park
country: United States
facility: Franklin Park Eye Center
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Shawnee Mission
country: United States
facility: Heart of America Eye Care, P.A.
state: Kansas
city: Medina
country: United States
facility: Wesley Optometric Consulting
state: Minnesota
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: