Trials / Terminated
TerminatedNCT04015219
Management of Signs and Symptoms Associated With Dry Eye Disease
A Prospective, Randomized, and Controlled Clinical Study to Evaluate PROKERA® in the Management of Signs and Symptoms Associated With Dry Eye Disease
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- BioTissue Holdings, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Self retained cryopreserved amniotic membrane | PROKERA SLIM |
| OTHER | lifitegrast ophthalmic solution | Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA) |
Timeline
- Start date
- 2018-07-18
- Primary completion
- 2020-10-05
- Completion
- 2020-10-05
- First posted
- 2019-07-10
- Last updated
- 2022-12-23
- Results posted
- 2022-12-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04015219. Inclusion in this directory is not an endorsement.