Management of Signs and Symptoms Associated With Dry Eye Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: Self retained cryopreserved amniotic membrane
* Other: lifitegrast ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>PROKERA SLIM + Standard of Care | Device: Self retained cryopreserved amniotic membrane<br>* PROKERA SLIM<br>Other: lifitegrast ophthalmic solution<br>* Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)<br>* Other names: Xiidra;|
| Active Comparator: Control Arm<br>Standard of Care | Other: lifitegrast ophthalmic solution<br>* Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)<br>* Other names: Xiidra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye Dryness Score | Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort | 1 month | 
| 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 |