Status:
TERMINATED
Management of Signs and Symptoms Associated With Dry Eye Disease
Lead Sponsor:
BioTissue Holdings, Inc
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04015219
Start Date
July 18 2018
End Date
October 5 2020
Last Update
December 23 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center of Excellence in Eye Care
Miami, Florida, United States, 33176