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Management of Signs and Symptoms Associated With Dry Eye Disease

NCT04015219 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-12-23

Study results available
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Summary

A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited.

Conditions

  • Dry Eye Syndromes

Interventions

DEVICE

Self retained cryopreserved amniotic membrane

PROKERA SLIM

OTHER

lifitegrast ophthalmic solution

Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)

Sponsors & Collaborators

  • BioTissue Holdings, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2020-10-05
Completion
2020-10-05
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 NCT04015219 on ClinicalTrials.gov