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High Refractive Index Material 510(k)

NCT00766168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2012-06-14

No results posted yet for this study

Summary

The purpose of this study is to establish the substantial equivalence of the HDS HI 1.54™ to the paflufocon C material control lenses to correct myopia and hyperopia with and without astigmatism. The purpose of the study is to profile the outcome endpoints and the patient acceptance of this Class II medical device.

Conditions

  • Myopia
  • Hyperopia

Interventions

OTHER

HDS HI 1.54; pahrifocon A

Contact Lens

DEVICE

FluoroPerm 30 RGP; paflufocon C

Contact lens daily wear

Sponsors & Collaborators

  • CooperVision International Limited (CVIL)

    lead INDUSTRY

Principal Investigators

  • Jerome A. Legerton, OD, MS · Consultant to Paragon Vision Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-08-31
Completion
2008-08-31

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 NCT00766168 on ClinicalTrials.gov