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Pilot Clinical Evaluation of Approved Contact Lenses

NCT02540122 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-06-20

No results posted yet for this study

Summary

This is a pilot evaluation to assess the feasibility of using novel imaging process to characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.

Conditions

  • Vision Disorders

Interventions

DEVICE

Marketed Contact Lens 1

Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).

DEVICE

Marketed Contact Lens 2

Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).

DEVICE

Marketed Contact Lens 3

Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).

DEVICE

Marketed Contact Lens 4

Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).

Sponsors & Collaborators

  • Johnson & Johnson Vision Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Hong Jiang, MD, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-06-30
Completion
2016-06-30
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 NCT02540122 on ClinicalTrials.gov