Management of Signs and Symptoms Associated With Dry Eye Disease

Dry Eye Syndromes Clinical Trial

Official title:

A Prospective, Randomized, and Controlled Clinical Study to Evaluate PROKERA® in the Management of Signs and Symptoms Associated With Dry Eye Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04015219
• Other study ID #: PROKERA-CS001
• Status: Terminated
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: October 5, 2020

Study information

• Verified date: December 2022
• Source: Tissue Tech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• Self retained cryopreserved amniotic membrane
PROKERA SLIM

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

Locations

Country	Name	City	State
United States	Center of Excellence in Eye Care	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tissue Tech Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Fluorescein Staining	corneal fluorescein staining score of study eye graded from 0 to 9, with a score of 9 being worse. The corneal fluorescein staining score is the sum of three scores by subdividing the entire cornea into upper 1/3, middle 1/3, and lower 1/3, of which each is graded from 0 (no staining) to 3 (diffuse staining).	1 month
Secondary	Eye Dryness Score	Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort	1 month
Secondary	Ocular Surface Disease Index (OSDI)	Patient subjectively evaluates OSDI questionnaire, OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability	1 month