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

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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

Trial documents
2

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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