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The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Not Applicable
Completed
Conditions
Refractive Ametropia
Registration Number
NCT05766787
Lead Sponsor
Alcon Research
Brief Summary

The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Detailed Description

In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
190
Inclusion Criteria
  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
  • Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
  • Willing to stop wearing habitual contact lenses for the duration of study participation.
  • Other protocol-specific inclusion criteria may apply.
Exclusion Criteria
  • Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
  • Habitual wear of AOHP contact lenses.
  • Habitual wear of any daily disposable contact lenses.
  • Other protocol-specified exclusion criteria may apply.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Least Squares Mean Distance VA With Study Lenses at Week 1Week 1 of each lens product worn during the corresponding crossover period

Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (15)

Kurata Eyecare Center

🇺🇸

Los Angeles, California, United States

Dr. Elsa Pao, OD

🇺🇸

Oakland, California, United States

Pacific Rims Optometry

🇺🇸

San Francisco, California, United States

Omega Vision Center P.A.

🇺🇸

Longwood, Florida, United States

Kindred Optics at Maitland Vision

🇺🇸

Maitland, Florida, United States

Vision Health Institute

🇺🇸

Orlando, Florida, United States

Tallahassee Eye Center

🇺🇸

Tallahassee, Florida, United States

Heart of America Eye Care

🇺🇸

Shawnee Mission, Kansas, United States

The Eye Doctors Inc

🇺🇸

Eden Prairie, Minnesota, United States

Complete Eye Care of Medina

🇺🇸

Medina, Minnesota, United States

Scroll for more (5 remaining)
Kurata Eyecare Center
🇺🇸Los Angeles, California, United States

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