A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo: a New Concept for Cataract Management
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|ClinicalTrials.gov Identifier: NCT03001466|
Recruitment Status : Completed
First Posted : December 23, 2016
Last Update Posted : December 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Drug Action Increased||Drug: urea-loaded nanoparticles eye drops Drug: Balance Salt Solution eye drops||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo: a New Concept for Cataract Management|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||September 2016|
Experimental: urea-loaded nanoparticles eye drops
This arm include 40 cases (67 eyes) received urea-loaded nanoparticles eye drops (one drop five times a day for 8 weeks)
Drug: urea-loaded nanoparticles eye drops
one drop five times a day for 8 weeks
Other Name: pluronic®F-127 (PF)
Placebo Comparator: Balance Salt Solution eye drops
This arm include 11 cases (22 eyes) recieved Balance Salt Solution eye drops (one drop five times a day for 8 weeks)
Drug: Balance Salt Solution eye drops
one drop five times a day for 8 weeks
Other Name: Balance Salt Solution
- the difference in the score of visual acuity. [ Time Frame: 6 months ]
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): NCT03001466
|Principal Investigator:||Hassan L Fahmy, Prof||Assiut university-Faculty of medicine|