Clinical trial NCT04980456: Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses
Official title: Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 257
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 compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Detailed description: Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an approved Informed Consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
* Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
* Willing to stop wearing habitual contact lenses for the duration of study participation.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
* Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
* Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Distance VA (logMAR) With Study Lenses
timeFrame: Day 30, each study product
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Alcon Investigator 8135
state: California
city: Oakland
country: United States
facility: Alcon Investigator 8062
state: California
city: San Francisco
country: United States
facility: Alcon Investigator 8106
state: California
city: Longwood
country: United States
facility: Alcon Investigator 6356
state: Florida
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
city: West Palm Beach
country: United States
facility: Alcon Investigator 6654
state: Florida
city: Pittsburg
country: United States
facility: Alcon Investigator 6567
state: Kansas
city: Louisville
country: United States
facility: Alcon Investigator 5582
state: Kentucky
city: Sterling Heights
country: United States
facility: Alcon Investigator 8097
state: Michigan
city: Willmar
country: United States
facility: Alcon Investigator 7980
state: Minnesota
city: New York
country: United States
facility: Alcon Investigator 8130
state: New York
city: Warwick
country: United States
facility: Alcon Investigator 6401
state: Rhode Island
city: Memphis
country: United States
facility: Alcon Investigator 6353
state: Tennessee
city: Austin
country: United States
facility: Alcon Investigator 8175
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: