Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.
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|ClinicalTrials.gov Identifier: NCT04018417|
Recruitment Status : Withdrawn (Reconsidered significance in light of newly published in vitro data.)
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fuchs' Endothelial Dystrophy||Drug: Amphotericin B||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-masked, Placebo-controlled Study of the Safety of Amphotericin 0.255 μg/mL in Optisol-GS|
|Actual Study Start Date :||July 3, 2019|
|Actual Primary Completion Date :||July 3, 2019|
|Actual Study Completion Date :||July 3, 2019|
Experimental: Amphotericin B
The eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution.
Drug: Amphotericin B
Drug concentration: 0.255 μg/mL
No Intervention: Control
The donor cornea will be stored in Optisol-GS per the eye bank's standard procedure.
- Endothelial cell density [ Time Frame: 6 months ]Central corneal endothelial cell density will be assessed by specular microscopy
- Incidence of post-keratoplasty fungal keratitis [ Time Frame: 6 months ]The incidence of post-keratoplasty fungal keratitis will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018417
|United States, Indiana|
|Price Vision Group|
|Indianapolis, Indiana, United States, 46260|
|Principal Investigator:||Francis W Price, Jr, MD||Price Vision Group|