Dry Eye Syndromes
Conditions
Brief 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.
Interventions
DEVICESelf retained cryopreserved amniotic membrane
PROKERA SLIM
OTHERlifitegrast ophthalmic solution
Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
Sponsors
BioTissue Holdings, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Fluorescein Staining | 1 month | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eye Dryness Score | 1 month | Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort |
| Ocular Surface Disease Index (OSDI) | 1 month | Patient subjectively evaluates OSDI questionnaire, OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm PROKERA SLIM + Standard of Care
Self retained cryopreserved amniotic membrane: PROKERA SLIM
lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA) | 2 |
| Control Arm Standard of Care
lifitegrast ophthalmic solution: Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA) | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | Treatment Arm | Total | Control Arm |
|---|---|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 4.2 | 63 years STANDARD_DEVIATION 15 | 46 years STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
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).
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Corneal Fluorescein Staining | 0.5 units on a scale | Standard Deviation 0.7 |
| Control Arm | Corneal Fluorescein Staining | 3 units on a scale | Standard Deviation 0 |
Secondary
Eye Dryness Score
Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Eye Dryness Score | 57.5 units on a scale | Standard Deviation 46 |
| Control Arm | Eye Dryness Score | 75 units on a scale | Standard Deviation 0 |
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
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Ocular Surface Disease Index (OSDI) | 64.5 units on a scale | Standard Deviation 35 |
| Control Arm | Ocular Surface Disease Index (OSDI) | 52 units on a scale | Standard Deviation 0 |