CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 194 enrolled
Drug / intervention
Test solution +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03278223
NCT03278223N/ACompleted
CompareCT.gov

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

OTE North America·interventional·Posted Sep 11, 2017·Updated Mar 26, 2021

In Brief

A clinical study evaluating Test solution and Control solution for Myopia and Hyperopia. Completed, enrolled 194 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyopia, Hyperopia
CountriesUnited Kingdom, United States
CollaboratorsVisioncare Research Ltd.

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 11, 2017
Enrollment StartAug 14, 2017
Primary CompletionNov 17, 2017
Study CompletionDec 20, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.8 years ago

Interventions

Test solutiondevice

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

Control solutiondevice

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