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One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System

NCT03278223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2021-03-26

Study results available
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Summary

The purpose of this study is to evaluate the clinical performance of the contact lens care product Oté Sensation in a representative population of soft contact lens wearers. For comparison, a widely used FDA approved soft lens multipurpose solution will be used as a control. This control product has been tested in previous clinical trials.

Conditions

  • Myopia
  • Hyperopia

Interventions

DEVICE

Test solution

A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.

DEVICE

Control solution

A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.

Sponsors & Collaborators

  • Visioncare Research Ltd.

    collaborator OTHER

  • OTE North America

    lead INDUSTRY

Principal Investigators

  • Frances L Nicklin, Bsc, MCOptom · Visioncare Research Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-14
Primary Completion
2017-11-17
Completion
2017-12-20
FDA Device
Yes

Countries

  • United States
  • United Kingdom

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 NCT03278223 on ClinicalTrials.gov