Evaluation of Delefilcon A Contact Lenses

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors

Treatments: Device: Delefilcon A contact lenses with different base curves and diameters; Device: Delefilcon A contact lenses with standard base curves and diameters

Study type: Interventional

Funder types: Industry

Identifiers

NCT06884202

CLU484-P007

Details and patient eligibility

About

The purpose of the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters.

Full description

Subjects will be expected to attend 4 office visits for an individual duration of participation of approximately 3 days.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

267 participants in 2 patient groups

LID023681, then LID006961

Other group

Description:

Delefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.

Treatment:

Device: Delefilcon A contact lenses with standard base curves and diameters

Device: Delefilcon A contact lenses with different base curves and diameters

LID006961, then LID023681

Other group

Description:

Delefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods.

Treatment:

Device: Delefilcon A contact lenses with standard base curves and diameters

Device: Delefilcon A contact lenses with different base curves and diameters