Evaluation of a new type of contact lenses for myopia correction

Clinical Evaluation of Overall Lens Fit of Delefilcon A Contact Lenses of Different Diameters and Base Curves

This study tests a new type of contact lens to see if it can help people with nearsightedness see better and feel more comfortable than regular lenses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Alcon Research (Industry-sponsored)
• Locations: 12 sites (Los Angeles, California and 11 other locations)
• Trial ID: NCT06884202 on ClinicalTrials.gov

What this trial studies

This study evaluates the fit characteristics of delefilcon A contact lenses, which come in various base curves and diameters, to determine their effectiveness for individuals with refractive errors, particularly myopia. Participants will attend four office visits over a period of approximately three days to assess the lenses' performance. The study aims to compare the new lenses with standard options to identify potential improvements in comfort and vision quality.

Who should consider this trial

Good fit: Ideal candidates are individuals who have been successful wearers of spherical soft contact lenses for at least 5 days a week and 6 hours a day over the past three months.

Not a fit: Patients with any anterior segment infections, inflammation, or abnormalities that contraindicate contact lens wear will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better-fitting contact lenses that enhance comfort and visual acuity for myopia patients.

How similar studies have performed: Other studies have shown success with similar approaches in evaluating contact lens fit and comfort, indicating a promising avenue for this research.

Eligibility criteria

Key Inclusion Criteria:

* Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and a minimum of 6 hours per day during the past 3 months;
* Able to wear contact lenses within a range of sphere powers from -2.00 and -4.00 diopters (D);
* Best Corrected Visual Acuity (BCVA) (with manifest refraction) better than or equal to 0.10 logarithm Minimum Angle of Resolution (logMAR ) in each eye.

Key Exclusion Criteria:

* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
* History of refractive surgery or plan to have refractive surgery during the study, or irregular cornea in either eye;
* Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates.

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Los Angeles, California and 11 other locations

• Kurata Eyecare Center — Los Angeles, California, United States (Recruiting)
• Elsa Pao, OD — Oakland, California, United States (Recruiting)
• Pacific Rims Optometry — San Francisco, California, United States (Recruiting)
• Pearson Research Center, PA — Longwood, Florida, United States (Recruiting)
• Kindred Optics at Maitland Vision — Maitland, Florida, United States (Recruiting)
• Eyeconic Family Eyecare — Dallas, Georgia, United States (Recruiting)
• SUNY College of Optometry Clinical Vision Research Center — New York, New York, United States (Recruiting)
• NC Eye Associates, OD, PLLC — Apex, North Carolina, United States (Recruiting)
• See Eye Care Optometry — Charlotte, North Carolina, United States (Recruiting)
• ProCare Vision Centers, Inc. — Granville, Ohio, United States (Recruiting)
• Eyecare Professionals, Inc — Powell, Ohio, United States (Recruiting)
• West Bay Eye Associates — Warwick, Rhode Island, United States (Recruiting)

Study contacts

• Study coordinator: Alcon Call Center

Conditions Refractive Errors; Myopia; Contact lenses