Clinical trial NCT06461455: Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
Official title: Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Astigmatism
Keywords: Myopia
Hyperopia
Multifocal
Toric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-06-17
Enrollment: 88
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 purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

Detailed description: Participants will be expected to attend 5 office visits for an individual duration of participation of approximately 64 days.

Eligibility criteria: Key Inclusion Criteria:

* Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;
* Willing to not use readers while wearing study contact lenses for duration of the study;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
* Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Monovision contact lens wearers and wearers of contact lens in one eye only;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Binocular visual acuity at distance (4 meters) at Day 30 with study lenses
timeFrame: Day 30 (-2/+1) of each wear period. A wear period is 30 days (-2/+1) according to randomization assignment.]
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Dr.Elsa Pao, O.D
state: California
city: San Francisco
country: United States
facility: Pacific Rims Optometry
state: California
city: Maitland
country: United States
facility: Drs. Giedd, P.A.
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: Medina
country: United States
facility: Wesley Optometric Consulting
state: Minnesota
city: Garner
country: United States
facility: Oculus Research, Inc.
state: North Carolina
city: Granville
country: United States
facility: ProCare Vision Centers, Inc.
state: Ohio
city: Powell
country: United States
facility: Insight Research Clinic LLC
state: Ohio
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
city: San Antonio
country: United States
facility: Dawn M. Rakich, OD
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: