Management of Signs and Symptoms Associated With Dry Eye Disease

TissueTech

Status: Terminated

Conditions: Dry Eye Syndromes

Treatments: Other: lifitegrast ophthalmic solution; Device: Self retained cryopreserved amniotic membrane

Study type: Interventional

Funder types: Industry

Identifiers

NCT04015219

PROKERA-CS001

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

PROKERA SLIM + Standard of Care

Treatment:

Device: Self retained cryopreserved amniotic membrane

Other: lifitegrast ophthalmic solution

Control Arm

Active Comparator group

Description:

Standard of Care

Treatment:

Other: lifitegrast ophthalmic solution