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Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D

NCT02553681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-08-12

No results posted yet for this study

Summary

This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.

Conditions

  • Ametropia

Interventions

DEVICE

roflufocon D contact lenses

HPT treated rigid contact lenses

DEVICE

RGP contact lenses made from roflufocon D

Sponsors & Collaborators

  • Hartwig Research Center

    collaborator INDUSTRY

  • Contamac Ltd

    lead INDUSTRY

Principal Investigators

  • Andreas Hartwig, PhD, FAAO · Hartwig Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-02-28
Completion
2017-02-16

Countries

  • Germany

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 NCT02553681 on ClinicalTrials.gov