Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT03001466
Status:
COMPLETED
Last Update Posted:
2016-12-23
First Post:
2016-10-01
Brief Title:
A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo a New Concept for Cataract Management
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo a New Concept for Cataract Management
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cataract is the leading cause of vision loss and blindness in the worldsurgery is the only available option to correct the problem and the major reasons for low cataract surgical rates include low demand because of fear of surgery high cost of surgery and poor visual results but new research raises the hope that someday cataracts could be cured with simple eye drops This is the first report for preparing urea-loaded NPs eye drops for cataract therapy Enhancement of the urea efficacy is accomplished by using polymeric NPs based on the amphiphilic block copolymer PluronicF-127 PF which is a hydrophilic nontoxic copolymer widely used as a pharmaceutical excipient for its stabilizing properties and capability to increase the solubility
Detailed Description:
51 patients with cataract were included in this study that started at December 2014 to April 2016 All cases collected from out patients clinic of Assiut University Hospital These patients were randomized into two groups Group Icontrol included 11 cases 22 eyes used Balance Salt Solution BSS eye drops Group II include 40 cases 67 eyes were treated by the prepared eye drops of urea NPs solution
Preparation of urea-loaded nanoparticles
First the investigators will test the safety of urea as eye drops by injecting urea in concentration of 96 mlmol in the anterior chamber of 6 rabbit eyes and the other eye of each rabbit will be used as control After 14 days enucleation of both eyes then will prepare extracted eye tissue for examination by light and electron microscopes
Urea solution will be then prepared for eye drops purpose by enhancing its efficacy using the polymeric NPs based on the amphiphilic block copolymer PluronicF-127 PF which is an A-B-A-type triblock copolymer consisting of polyoxyethylene PEO units A and polyoxypropylene PPO units B with a thermoreversible gelation property that has a hydrophilic nontoxic property widely used as a pharmaceutical excipient for its stabilizing properties and capability to increase the solubility
The eye drop will be prepared by an ionic gelation method using the tripeptide antioxidant glutathione GSH with the pluronicF-127 PF as carriers to urea delivery for the target of cataract therapy Pluronic F127 PF127 which can be self-assembled into micelles upon increasing concentration or raising temperatures is used to decorate the water-soluble urea via a chemical reaction Next the GSH is incorporated into the hydrophobic poly propylene oxide compartment of PF127 using electrostatic interactions between the positively charged GSH and the negatively charged PF The prepared NPs were then characterized using transmission electron microscopy TEM The average size of urea-loaded PF 127GSH NPs was 140 nm
Preparation of urea-loaded nanoparticles
First the investigators will test the safety of urea as eye drops by injecting urea in concentration of 96 mlmol in the anterior chamber of 6 rabbit eyes and the other eye of each rabbit will be used as control After 14 days enucleation of both eyes then will prepare extracted eye tissue for examination by light and electron microscopes
Urea solution will be then prepared for eye drops purpose by enhancing its efficacy using the polymeric NPs based on the amphiphilic block copolymer PluronicF-127 PF which is an A-B-A-type triblock copolymer consisting of polyoxyethylene PEO units A and polyoxypropylene PPO units B with a thermoreversible gelation property that has a hydrophilic nontoxic property widely used as a pharmaceutical excipient for its stabilizing properties and capability to increase the solubility
The eye drop will be prepared by an ionic gelation method using the tripeptide antioxidant glutathione GSH with the pluronicF-127 PF as carriers to urea delivery for the target of cataract therapy Pluronic F127 PF127 which can be self-assembled into micelles upon increasing concentration or raising temperatures is used to decorate the water-soluble urea via a chemical reaction Next the GSH is incorporated into the hydrophobic poly propylene oxide compartment of PF127 using electrostatic interactions between the positively charged GSH and the negatively charged PF The prepared NPs were then characterized using transmission electron microscopy TEM The average size of urea-loaded PF 127GSH NPs was 140 nm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None