Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Errors

• Registration Number: NCT05431478
• 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 study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Study Start: 2022-07-15
• Status Verified: 2022-09
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-09
• Results First Submitted: 2023-08-24
• Results First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 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-specified inclusion criteria may apply.

Key

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

Name	Time	Method
Visual Acuity With Study Lenses at Week 1 Follow-Up	Week 1, each wear period. A wear period was approximately 14 days.	Visual acuity (VA) was assessed with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint.

Trial Locations

Locations (5)

Drs. Giedd, PA; 🇺🇸 Maitland, Florida, United States

Wesley Optometric Consulting; 🇺🇸 Medina, Minnesota, United States

ProCare Vision Center; 🇺🇸 Granville, Ohio, United States

West Bay Eye Associates; 🇺🇸 Warwick, Rhode Island, United States

Optometry Group, PLLC; 🇺🇸 Memphis, Tennessee, United States