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Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a Presbyopic Population

NCT04534517 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2022-01-13

Study results available
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Summary

The clinical study is a bilateral, single-masked (partial), single-arm, clinical trial. A total of approximately 60 eligible subjects both near-sighted and far-sighted, will be targeted to complete the study. Subjects will be fit in the study lens for approximately 2-4 days then undergo lens optimization, if required. Subjects will then be given a new pair of lenses that will be worn for approximately 2 weeks.

Conditions

  • Visual Acuity

Interventions

DEVICE

JJV Investigational Multifocal Contact Lens

TEST Lens

DEVICE

ACUVUE OASYS® with HYDRACLEAR® PLUS

The spherical test lens was used in the troubleshooting steps only for low ADD subjects who have reported a distance vision complaint.

Sponsors & Collaborators

  • Johnson & Johnson Vision Care, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2020-09-29
Completion
2020-09-29
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 NCT04534517 on ClinicalTrials.gov