Clinical trial NCT04422990: Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens
Official title: Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Vision Correction
Contact Lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 158
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 study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Detailed description: Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3-4 months in this daily wear clinical study.

Eligibility criteria: Key Inclusion Criteria:

* Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day;
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;
* Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Wearing 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;
* Habitually wearing Biofinity lenses;
* Monovision or multifocal contact lens wearers;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up
timeFrame: Week 1 Follow-Up
Secondary outcomes:
measure: Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up
timeFrame: Week 1 Follow-Up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Alcon Investigative Site
state: California
city: Novato
country: United States
facility: Alcon Investigative Site
state: California
city: Oakland
country: United States
facility: Alcon Investigative Site
state: California
city: Oakland
country: United States
facility: Alcon Investigative Site
state: California
city: San Francisco
country: United States
facility: Alcon Investigative Site
state: California
city: Orlando
country: United States
facility: Alcon Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Alcon Investigative Site
state: Florida
city: Downers Grove
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Louisville
country: United States
facility: Alcon Investigative Site
state: Kentucky
city: New York
country: United States
facility: Alcon Investigative Site
state: New York
city: Cleveland
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Boiling Springs
country: United States
facility: Alcon Investigative Site
state: South Carolina
city: Plano
country: United States
facility: Alcon Investigative Site
state: Texas
city: Wichita Falls
country: United States
facility: Alcon Investigative Site
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Vision Care
role: STUDY_DIRECTOR
References: