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

NCT03001466 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-12-23

No results posted yet for this study

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.

Conditions

  • Drug Action Increased

Interventions

DRUG

urea-loaded nanoparticles 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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Hassan L Fahmy, Prof · Assiut university-Faculty of medicine

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2016-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03001466 on ClinicalTrials.gov