A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo: a New Concept for Cataract Management
Condition: Drug Action Increased
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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 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.
    

Intervention name(s): urea-loaded nanoparticles eye drops; Balance Salt Solution eye drops
Intervention type(s): Drug; Drug
Intervention description(s): one drop five times a day for 8 weeks; one drop five times a day for 8 weeks
Other intervention name(s): pluronic®F-127 (PF); Balance Salt Solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Cataract; Urea-loaded NPs; TEM examination