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Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear

NCT03722784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-10-01

Study results available
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Summary

The aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality.

Conditions

  • Myopia
  • Hyperopia
  • Astigmatism

Interventions

DEVICE

Invigor A (test)

silicone hydrogel lens

DEVICE

Invigor B (control)

silicone hydrogel lens

Sponsors & Collaborators

  • CooperVision, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Quinn, O.D · Quinn, Foster & Associates, OH

  • Peter Van Hoven, O.D · Primary Eyecare group, P.C, TN

  • Mark Nakano, O.D · Mark Nakano, O.D, CA

  • David Ziegler, O.D · Ziegler Leffingwell Eye Center, WI

  • Cheryl Vincent Riemer, O.D · Vision Care Associates, MI

  • Carmen Castellano, O.D · The Koetting Associates, MO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2019-01-18
Completion
2019-06-01
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 NCT03722784 on ClinicalTrials.gov