Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Completed · Not applicable

Conditions studied: Refractive Ametropia

In brief

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.

Key facts

Study ID

NCT04085328

Run by

Alcon Research

People needed

675

Starts

2019-10-11

Expected to finish

2021-03-26

Last updated by the study team

2023-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Family EyeCare Center — Campbell, California, United States
• Winston Eye Care — Fullerton, California, United States
• Kurata Eye Care Center — Los Angeles, California, United States
• East West Eye Institute — Los Angeles, California, United States
• Dr.Elsa Pao, O.D — Oakland, California, United States
• Gordon Schanzlin New Vision Institute — San Diego, California, United States
• Complete Family Vision Care — San Diego, California, United States
• Westview Optometry — San Diego, California, United States
• OMEGA Vision Center PA, DBA Sabal Eye Care — Longwood, Florida, United States
• Kindred Optics at Maitland Vision Center — Maitland, Florida, United States
• Mid Florida Eye Center, PA — Mt. Dora, Florida, United States
• Eola Eyes — Orlando, Florida, United States
• Vision Health Institute — Orlando, Florida, United States
• Visual Performance Center Research & Development — Pensacola, Florida, United States
• Golden Vision — Sarasota, Florida, United States
• Advanced Eyecare Specialists — West Palm Beach, Florida, United States
• VisionPoint Eye Center — Bloomington, Illinois, United States
• Franklin Park Eye Center, PC — Franklin Park, Illinois, United States
• Kannarr Eye Care, LLC — Pittsburg, Kansas, United States
• Optimum Vision Care — Brighton, Massachusetts, United States
• Fraser Eye Care Center — Fraser, Michigan, United States
• Dr. Schwartz Optometrist and Associates — Sterling Heights, Michigan, United States
• Complete Eye Care of Medina — Medina, Minnesota, United States
• Fischer Laser Eye Center, LLC — Willmar, Minnesota, United States
• Tekwnai Vision Center, Inc — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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