A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens

NCT02518490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-09-22

Study results available
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Summary

This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear.

The study results were not used for design validation of test lens.

Conditions

  • Myopia

Interventions

DEVICE

Sapphire Lens

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

DEVICE

enfilcon A

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Sponsors & Collaborators

  • CooperVision, Inc.

    lead INDUSTRY

Principal Investigators

  • Meng Lin · Clinical Research Center, University of California, Berkeley

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-09-30
Completion
2015-10-31
FDA Device
Yes

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 NCT02518490 on ClinicalTrials.gov