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A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo: a New Concept for Cataract Management

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03001466
Collaborator
(none)
50
Enrollment
2
Arms
32
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: urea-loaded nanoparticles eye drops
  • Drug: Balance Salt Solution eye drops
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
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 :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Balance Salt Solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the difference in the score of visual acuity. [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All cases were immature cataract at different stages.
    Exclusion Criteria:
    • No complicated cataract included in this study either due to local or systemic diseases.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Hassan L Fahmy, Prof, Assiut university-Faculty of medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heba Mohamed Saad Eldien, Professor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03001466
    Other Study ID Numbers:
    • NCCM
    First Posted:
    Dec 23, 2016
    Last Update Posted:
    Dec 23, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Heba Mohamed Saad Eldien, Professor, Assiut University
    Cataract
    Urea-loaded NPs
    TEM examination
    Additional relevant MeSH terms:
    Cataract
    Pharmaceutical Solutions
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Dec 23, 2016