Clinical trial NCT05766787: The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Official title: The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Ametropia
Keywords: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 190
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 purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Detailed description: In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.

Eligibility criteria: Inclusion Criteria:

* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
* Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
* Willing to stop wearing habitual contact lenses for the duration of study participation.
* Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

* Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
* Habitual wear of AOHP contact lenses.
* Habitual wear of any daily disposable contact lenses.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Distance VA With Study Lenses at Week 1
timeFrame: Week 1 of each lens product worn during the corresponding crossover period
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kurata Eyecare Center
state: California
city: Oakland
country: United States
facility: Dr. Elsa Pao, OD
state: California
city: San Francisco
country: United States
facility: Pacific Rims Optometry
state: California
city: Longwood
country: United States
facility: Omega Vision Center P.A.
state: Florida
city: Maitland
country: United States
facility: Kindred Optics at Maitland Vision
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Eye Center
state: Florida
city: Shawnee Mission
country: United States
facility: Heart of America Eye Care
state: Kansas
city: Eden Prairie
country: United States
facility: The Eye Doctors Inc
state: Minnesota
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: New York
country: United States
facility: SUNY College of Optometry Clinical Vision Research Center
state: New York
city: Granville
country: United States
facility: ProCare Vision Centers, Inc.
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
city: Memphis
country: United States
facility: Total Eye Care PA
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead Alcon Vision Care
role: STUDY_DIRECTOR
References: