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

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT04980456
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-28
• Study Start: 2021-08-05
• Primary Completion: 2021-11-20
• Study Completion: 2021-11-20
• Results First Submitted: 2022-11-16
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-13
• Last Update Submitted: 2022-12-13
• Results First Posted: 2023-01-06
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Distance VA (logMAR) With Study Lenses	Day 30, each study product	Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Trial Locations

Locations (14)

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

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