MedPath

Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

Not Applicable
Completed
Conditions
Refractive Errors
Registration Number
NCT05050578
Lead Sponsor
Alcon Research
Brief Summary

The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

Detailed Description

Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
166
Inclusion Criteria
  • Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
  • Manifest cylinder less than or equal to 0.75 diopter in each eye.
  • Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
  • Other protocol-defined inclusion criteria may apply.

Key

Exclusion Criteria
  • Monovision or multifocal lens wearer.
  • Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
  • Routinely sleeps in habitual contact lenses.
  • Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30Day 30, each study lens type

Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (10)

Dr. Elsa Pao, OD

🇺🇸

Oakland, California, United States

Pacific Rims Optometry

🇺🇸

San Francisco, California, United States

Sabal Eye Care

🇺🇸

Longwood, Florida, United States

Vision Health Institute

🇺🇸

Orlando, Florida, United States

West Bay Eye Associates

🇺🇸

Warwick, Rhode Island, United States

North Spartanburg Eye Center

🇺🇸

Boiling Springs, South Carolina, United States

Optometry Group, PLLC

🇺🇸

Memphis, Tennessee, United States

Advancing Vision Research, LLC

🇺🇸

Smyrna, Tennessee, United States

Dr Christina R Chang & Associates, OD, PA

🇺🇸

Plano, Texas, United States

Dawn M. Rakich, OD

🇺🇸

San Antonio, Texas, United States

Dr. Elsa Pao, OD
🇺🇸Oakland, California, United States

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