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Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

NCT04178720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2021-10-19

Study results available
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Summary

The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Conditions

  • Refractive Errors

Interventions

DEVICE

Lehfilcon A contact lenses

Investigational silicone hydrogel contact lenses

DEVICE

Comfilcon A contact lenses

Commercially available silicone hydrogel contact lenses

DEVICE

CLEAR CARE

Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • CDMA Project Lead, Vision Care · Alcon Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-28
Primary Completion
2020-06-10
Completion
2020-06-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178720 on ClinicalTrials.gov