Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

Completed · Not applicable

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT04980456

Run by

Alcon Research

People needed

257

Starts

2021-08-05

Expected to finish

2021-11-20

Last updated by the study team

2023-01-06

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alcon Investigator 8135 — Los Angeles, California, United States
• Alcon Investigator 8062 — Oakland, California, United States
• Alcon Investigator 8106 — San Francisco, California, United States
• Alcon Investigator 6356 — Longwood, Florida, United States
• Alcon Investigator 6565 — Maitland, Florida, United States
• Alcon Investigator 6654 — West Palm Beach, Florida, United States
• Alcon Investigator 6567 — Pittsburg, Kansas, United States
• Alcon Investigator 5582 — Louisville, Kentucky, United States
• Alcon Investigator 8097 — Sterling Heights, Michigan, United States
• Alcon Investigator 7980 — Willmar, Minnesota, United States
• Alcon Investigator 8130 — New York, New York, United States
• Alcon Investigator 6401 — Warwick, Rhode Island, United States
• Alcon Investigator 6353 — Memphis, Tennessee, United States
• Alcon Investigator 8175 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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