Clinical trial NCT04085328: Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
Official title: Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Ametropia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 675
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.

Detailed description: Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an Informed Consent Form.
* Willing to attend all scheduled study visits as required per protocol.
* Willing and able to wear assigned study lenses as required per protocol.
* Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
* Manifest cylinder ≤ 0.75 diopter (D) in each eye.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any eye infection, inflammation, or 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 eye surgery, including refractive surgery.
* Currently pregnant or breast-feeding.
* Monovision contact lens wearers.
* Daily disposable contact lens wearers.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
timeFrame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up
measure: Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
timeFrame: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up
measure: Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)
timeFrame: Up to Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Family EyeCare Center
state: California
city: Fullerton
country: United States
facility: Winston Eye Care
state: California
city: Los Angeles
country: United States
facility: Kurata Eye Care Center
state: California
city: Los Angeles
country: United States
facility: East West Eye Institute
state: California
city: Oakland
country: United States
facility: Dr.Elsa Pao, O.D
state: California
city: San Diego
country: United States
facility: Gordon Schanzlin New Vision Institute
state: California
city: San Diego
country: United States
facility: Complete Family Vision Care
state: California
city: San Diego
country: United States
facility: Westview Optometry
state: California
city: Longwood
country: United States
facility: OMEGA Vision Center PA, DBA Sabal Eye Care
state: Florida
city: Maitland
country: United States
facility: Kindred Optics at Maitland Vision Center
state: Florida
city: Mount Dora
country: United States
facility: Mid Florida Eye Center, PA
state: Florida
city: Orlando
country: United States
facility: Eola Eyes
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Pensacola
country: United States
facility: Visual Performance Center Research & Development
state: Florida
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: West Palm Beach
country: United States
facility: Advanced Eyecare Specialists
state: Florida
city: Bloomington
country: United States
facility: VisionPoint Eye Center
state: Illinois
city: Franklin Park
country: United States
facility: Franklin Park Eye Center, PC
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care, LLC
state: Kansas
city: Brighton
country: United States
facility: Optimum Vision Care
state: Massachusetts
city: Fraser
country: United States
facility: Fraser Eye Care Center
state: Michigan
city: Sterling Heights
country: United States
facility: Dr. Schwartz Optometrist and Associates
state: Michigan
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Willmar
country: United States
facility: Fischer Laser Eye Center, LLC
state: Minnesota
city: Saint Louis
country: United States
facility: Tekwnai Vision Center, Inc
state: Missouri
city: Poughkeepsie
country: United States
facility: Alterman, Modi & Wolter
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates, PLLC
state: North Carolina
city: Granville
country: United States
facility: ProCare Vision Centers, Inc.
state: Ohio
city: Piqua
country: United States
facility: Midwest Vision Care
state: Ohio
city: Powell
country: United States
facility: EyeCare Professionals, Inc. DBA Insight Research Clinic, LLC
state: Ohio
city: Wyomissing
country: United States
facility: Wyomissing Optometric Center
state: Pennsylvania
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Boiling Springs
country: United States
facility: North Spartanburg Eye Center
state: South Carolina
city: Brentwood
country: United States
facility: Primary Eyecare Group, PC
state: Tennessee
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research, LLC
state: Tennessee
city: Beaumont
country: United States
facility: Beaumont Family Eye Care
state: Texas
city: Katy
country: United States
facility: Vision One Eyecare
state: Texas
city: San Antonio
country: United States
facility: Dawn M Rakich, OD
state: Texas
city: Wichita Falls
country: United States
facility: Clarke EyeCare Center
state: Texas
Study officials:
affiliation: Alcon Research
name: Alcon Study Director
role: STUDY_DIRECTOR
References: