MedDataX Logo

Management of Signs and Symptoms Associated With Dry Eye Disease

NCT ID: NCT04015219

Last Updated: 2022-12-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2020-10-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Arm

PROKERA SLIM + Standard of Care

Group Type EXPERIMENTAL

Self retained cryopreserved amniotic membrane

Intervention Type DEVICE

PROKERA SLIM

lifitegrast ophthalmic solution

Intervention Type OTHER

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

Control Arm

Standard of Care

Group Type ACTIVE_COMPARATOR

lifitegrast ophthalmic solution

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self retained cryopreserved amniotic membrane

PROKERA SLIM

Intervention Type DEVICE

lifitegrast ophthalmic solution

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Xiidra

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects with moderate dry eye defined as corneal fluorescein staining score of ≥ 3
* Age ≥ 18 years
* Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
* Willing to sign a written informed consent to participate
* Able to follow study instructions, with the intention of completing all required visits

Exclusion Criteria

* Presence of persistent corneal epithelial defect or ulcer in either eye
* Presence of active ocular infection in either eye
* Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis
* Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis
* Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD)
* Contact lens wear
* History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
* Presence of cicatricial ocular surface diseases
* A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
* Any scheduled or planned ocular or systemic surgery or procedure during the study
* Pregnancy and women who are expecting to be pregnant.
* Current enrolment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BioTissue Holdings, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center of Excellence in Eye Care

Miami, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PROKERA-CS001

Identifier Type: -

Identifier Source: org_study_id