Drug Action Increased Clinical Trial
Official title:
A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo: a New Concept for Cataract Management
Verified date | December 2016 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | September 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 45 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the difference in the score of visual acuity. | 6 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Phase 4 |