Clinical trial NCT05338333: Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Official title: Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Contact lenses
Multifocal
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 101
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.

Detailed description: Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
* Willing and able to attend all study visits as required by the protocol.
* Willing to stop wearing habitual contact lenses for the duration of the study.
* Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
* Other protocol-specified inclusion criteria may apply.

Key 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.
* History of refractive surgery or planning to have refractive surgery during the study.
* Current or history of pathologically dry eye.
* Currently pregnant or lactating.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses
timeFrame: Day 30, each wear period. A wear period was approximately 30 days.
Secondary outcomes:
Other outcomes:
Locations:
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: Pittsburg
country: United States
facility: Kannarr Eye Care LLC
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: 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
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: