<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03001466</url>
  </required_header>
  <id_info>
    <org_study_id>NCCM</org_study_id>
    <nct_id>NCT03001466</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo: a New Concept for Cataract Management</brief_title>
  <official_title>A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo: a New Concept for Cataract Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cataract is the leading cause of vision loss and blindness in the world,surgery is the only&#xD;
      available option to correct the problem and the major reasons for low cataract surgical rates&#xD;
      include low demand because of fear of surgery, high cost of surgery and poor visual results&#xD;
      but new research raises the hope that someday, cataracts could be cured with simple eye&#xD;
      drops. This is the first report for preparing urea-loaded NPs eye drops for cataract therapy.&#xD;
      Enhancement of the urea efficacy is accomplished by using polymeric NPs based on the&#xD;
      amphiphilic block copolymer Pluronic®F-127 (PF) which is a hydrophilic nontoxic copolymer&#xD;
      widely used as a pharmaceutical excipient for its stabilizing properties and capability to&#xD;
      increase the solubility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      51 patients with cataract were included in this study that started at December 2014 to April&#xD;
      2016. All cases collected from out patients' clinic of Assiut University Hospital These&#xD;
      patients were randomized into two groups. Group I(control) included 11 cases (22 eyes) used&#xD;
      Balance Salt Solution (BSS) eye drops. Group II include 40 cases (67 eyes) were treated by&#xD;
      the prepared eye drops of urea NPs solution.&#xD;
&#xD;
      Preparation of urea-loaded nanoparticles&#xD;
&#xD;
      First the investigators will test the safety of urea as eye drops by injecting urea in&#xD;
      concentration of 96 ml/mol in the anterior chamber of 6 rabbit eyes and the other eye of each&#xD;
      rabbit will be used as control. After 14 days enucleation of both eyes, then will prepare&#xD;
      extracted eye tissue for examination by light and electron microscopes.&#xD;
&#xD;
      Urea solution will be then prepared for eye drops purpose by enhancing its efficacy using the&#xD;
      polymeric NPs based on the amphiphilic block copolymer Pluronic®F-127 (PF) which is an&#xD;
      A-B-A-type triblock copolymer consisting of polyoxyethylene (PEO) units (A) and&#xD;
      polyoxypropylene (PPO) units (B) with a thermoreversible gelation property that has a&#xD;
      hydrophilic nontoxic property widely used as a pharmaceutical excipient for its stabilizing&#xD;
      properties and capability to increase the solubility.&#xD;
&#xD;
      The eye drop will be prepared by an ionic gelation method using the tripeptide antioxidant&#xD;
      glutathione (GSH) with the pluronic®F-127 (PF) as carriers to urea delivery for the target of&#xD;
      cataract therapy. Pluronic® F127 (PF127), which can be self-assembled into micelles upon&#xD;
      increasing concentration or raising temperatures, is used to decorate the water-soluble urea&#xD;
      via a chemical reaction. Next, the GSH is incorporated into the hydrophobic poly (propylene&#xD;
      oxide) compartment of PF127 using electrostatic interactions between the positively charged&#xD;
      GSH and the negatively charged PF. The prepared NPs were then characterized using&#xD;
      transmission electron microscopy (TEM). The average size of urea-loaded PF 127/GSH NPs was&#xD;
      140 nm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the difference in the score of visual acuity.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Drug Action Increased</condition>
  <arm_group>
    <arm_group_label>urea-loaded nanoparticles eye drops</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm include 40 cases (67 eyes) received urea-loaded nanoparticles eye drops (one drop five times a day for 8 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Balance Salt Solution eye drops</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This arm include 11 cases (22 eyes) recieved Balance Salt Solution eye drops (one drop five times a day for 8 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>urea-loaded nanoparticles eye drops</intervention_name>
    <description>one drop five times a day for 8 weeks</description>
    <arm_group_label>urea-loaded nanoparticles eye drops</arm_group_label>
    <other_name>pluronic®F-127 (PF)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Balance Salt Solution eye drops</intervention_name>
    <description>one drop five times a day for 8 weeks</description>
    <arm_group_label>Balance Salt Solution eye drops</arm_group_label>
    <other_name>Balance Salt Solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All cases were immature cataract at different stages.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No complicated cataract included in this study either due to local or systemic&#xD;
             diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hassan L Fahmy, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut university-Faculty of medicine</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Heba Mohamed Saad Eldien</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cataract</keyword>
  <keyword>Urea-loaded NPs</keyword>
  <keyword>TEM examination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03001466
org study id: NCCM
nct id: NCT03001466
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: the difference in the score of visual acuity.
time frame: 6 months
arm group label: urea-loaded nanoparticles eye drops
arm group type: Experimental
description: This arm include 40 cases (67 eyes) received urea-loaded nanoparticles eye drops (one drop five times a day for 8 weeks)
arm group label: Balance Salt Solution eye drops
arm group type: Placebo Comparator
description: This arm include 11 cases (22 eyes) recieved Balance Salt Solution eye drops (one drop five times a day for 8 weeks)
intervention type: Drug
intervention name: urea-loaded nanoparticles eye drops
description: one drop five times a day for 8 weeks
arm group label: urea-loaded nanoparticles eye drops
other name: pluronic®F-127 (PF)
intervention type: Drug
intervention name: Balance Salt Solution eye drops
description: one drop five times a day for 8 weeks
arm group label: Balance Salt Solution eye drops
other name: Balance Salt Solution
criteria: 
gender: All
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hassan L Fahmy, Prof
role: Principal Investigator
affiliation: Assiut university-Faculty of medicine
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Heba Mohamed Saad Eldien
investigator title: Professor
mesh term: Cataract
mesh term: Pharmaceutical Solutions
mesh term: Ophthalmic Solutions
sharing ipd: No