Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: CLEAR CARE; Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04422990

CLY935-C012

Details and patient eligibility

About

The purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Full description

Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3-4 months in this daily wear clinical study.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day;
• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;
• Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
• Habitually wearing Biofinity lenses;
• Monovision or multifocal contact lens wearers;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

158 participants in 2 patient groups

LID018869

Experimental group

Description:

Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.

Treatment:

Device: CLEAR CARE

Device: Lehfilcon A contact lenses

Biofinity

Active Comparator group

Description:

Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.

Treatment:

Device: CLEAR CARE

Device: Comfilcon A contact lenses