Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors; Ametropia

Treatments: Device: Comfilcon A contact lenses; Device: Hydrogen peroxide-based cleaning and disinfecting solution; Device: Senofilcon A contact lenses; Device: Lehfilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04532099

CLY935-C020

Details and patient eligibility

About

The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).

Full description

Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.

Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Sign an approved Informed Consent Form.
• Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
• History of refractive surgery or plan to have refractive surgery during the study.
• Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
• Routinely sleeps in contact lenses at least 1 night per week.
• Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
• Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

132 participants in 3 patient groups

LID018869, then AOHP (Part A)

Other group

Description:

Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.

Treatment:

Device: Lehfilcon A contact lenses

Device: Senofilcon A contact lenses

Device: Hydrogen peroxide-based cleaning and disinfecting solution

AOHP, then LID018869 (Part A)

Other group

Description:

Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.

Treatment:

Device: Lehfilcon A contact lenses

Device: Senofilcon A contact lenses

Device: Hydrogen peroxide-based cleaning and disinfecting solution

Biofinity (Part B)

Active Comparator group

Description:

Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.

Treatment:

Device: Hydrogen peroxide-based cleaning and disinfecting solution

Device: Comfilcon A contact lenses