Clinical trial NCT04207749: Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
Official title: Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Myopia
Hyperopia
Keywords: Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-12-23
Enrollment: 249
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 assess 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 with frequent replacement.

Detailed description: Subjects will 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 months.

Eligibility criteria: Key Inclusion Criteria:

* Understand and sign an IRB/IEC approved Informed Consent form.
* Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
* Successful wear of frequent replacement, spherical, daily wear 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 ≤ 0.75 diopter (D) in each eye.
* Best spectacle corrected visual acuity 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.
* Monovision contact lens wear.
* Any habitual wear of Biofinity lenses.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
timeFrame: Week 1 Follow-Up
Secondary outcomes:
measure: Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)
timeFrame: Week 1 Follow-Up, at least 4 hours after lens insertion
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Alcon Investigator 8103
state: Arizona
city: Brentwood
country: United States
facility: Alcon Investigator 8101
state: California
city: Irvine
country: United States
facility: Alcon Investigator 8102
state: California
city: Los Angeles
country: United States
facility: Alcon Investigator 8135
state: California
city: Novato
country: United States
facility: Alcon Investigator 8108
state: California
city: Oakland
country: United States
facility: Alcon Investigator 8062
state: California
city: San Francisco
country: United States
facility: Alcon Investigator 8109
state: California
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
city: Orlando
country: United States
facility: Alcon Investigator 6355
state: Florida
city: Norcross
country: United States
facility: Alcon Investigator 8115
state: Georgia
city: Pittsburg
country: United States
facility: Alcon Investigator 6567
state: Kansas
city: Brighton
country: United States
facility: Alcon Investigator 8063
state: Massachusetts
city: New York
country: United States
facility: Alcon Investigator 8100
state: New York
city: Cleveland
country: United States
facility: Alcon Investigator 4817
state: Ohio
city: Powell
country: United States
facility: Alcon Investigator 6313
state: Ohio
city: Warwick
country: United States
facility: Alcon Investigator 6401
state: Rhode Island
city: Memphis
country: United States
facility: Alcon Investigator 6353
state: Tennessee
city: Plano
country: United States
facility: Alcon Investigator 8114
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Vision Care
role: STUDY_DIRECTOR
References: