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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
Sponsor:
Information provided by (Responsible Party):
Heba Mohamed Saad Eldien, Assiut University

Study Description
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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 Action Increased 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
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Study Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Sodium

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. the difference in the score of visual acuity. [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Hassan L Fahmy, Prof Assiut university-Faculty of medicine
More Information
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Responsible Party: Heba Mohamed Saad Eldien, Professor, Assiut University
ClinicalTrials.gov Identifier: NCT03001466    
Other Study ID Numbers: NCCM
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Heba Mohamed Saad Eldien, Assiut University:
Cataract
Urea-loaded NPs
TEM examination
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions