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Clinical Evaluation of the Safety and Efficacy of FID 120947A

NCT02771145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2019-01-10

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.

Conditions

  • Refractive Error

Interventions

DEVICE

FID 120947A contact lens disinfecting solution

Investigational 3% hydrogen peroxide solution that uses a platinum catalyst for neutralization and is intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses

DEVICE

Soft contact lenses (SCL)

Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (180 days). A fresh pair will be dispensed on Day 0, Day 30, Day 60, and Day 135.

DEVICE

SCL preservative solution

Commercially available solution for rinsing soft contact lenses

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Group Manager, Clinical Development · Alcon Japan, Ltd.

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-20
Primary Completion
2017-01-10
Completion
2017-01-10

Countries

  • Japan

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 NCT02771145 on ClinicalTrials.gov