Drug Action Increased Clinical Trial
Official title:
A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo: a New Concept for Cataract Management
Cataract is the leading cause of vision loss and blindness in the world,surgery 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 Pluronic®F-127 (PF) which is a hydrophilic nontoxic copolymer widely used as a pharmaceutical excipient for its stabilizing properties and capability to increase the solubility.
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 I(control) 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 ml/mol 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 Pluronic®F-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 pluronic®F-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 127/GSH NPs was
140 nm.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01341964 -
Clopidogrel and Aspirin Interaction Study-2
|
Phase 4 |