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

NCT03001466 | Completed Phase 2 DMC

• 1 other identifier: NCCM
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Drug Action Increased

Keywords

Cataract; Urea-loaded NPs; TEM examination

Outcome Measures

Primary Outcomes (1)

• the difference in the score of visual acuity.

  6 months

Study Arms (2)

urea-loaded nanoparticles eye drops

EXPERIMENTAL

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

Balance Salt Solution eye drops

PLACEBO COMPARATOR

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

Interventions

urea-loaded nanoparticles eye drops DRUG

one drop five times a day for 8 weeks

Also known as: pluronic®F-127 (PF)

urea-loaded nanoparticles eye drops

Balance Salt Solution eye drops DRUG

one drop five times a day for 8 weeks

Also known as: Balance Salt Solution

Balance Salt Solution eye drops

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All cases were immature cataract at different stages.

You may not qualify if:

• No complicated cataract included in this study either due to local or systemic diseases.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Hassan L Fahmy, Prof

  Assiut university-Faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2016
• First Posted: December 23, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 23, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share