Clinical Trials Logo
  1. Home
  2. Corneal Ulcer
  3. NCT01242839

Randomized Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing — UNICOL  

Corneal Ulcer Clinical Trial

Official title:
Randomized Multicentric Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing

Clinical Trial Summary

CACICOL20 is a biodegradable nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Applied to the corneal lesion, it replaces damaged heparan sulfates in the matrix scaffold. CACICOL20 binds to matrix proteins such as collagen and cytokines or endogenous growth factors of the cellular microenvironment. CACICOL20 provides a protective function and restores the matrix architecture. This produces a suitable spatial environment for cells to respond properly to the cascade of signals needed for tissue regeneration to resume.

The ophthalmic solution, CACICOL20, used for corneal ulcers is very well tolerated both locally and generally, as proved by a pilot study which as been conducted at the "Hôpital des XV-XX" in Paris (France). It reduces the pain significantly and increases corneal ulcer healing (all ulcers treated were resistant to all other usual therapies).

Therefore, the accuracy of a Randomized multicentric double blinded study to evaluate the efficacy of CACICOL20 versus placebo for chronic corneal ulcer healing has been shown and will begin mid-may 2010. In this study, CACICOL20 will be applied every 2 or 4 days for 3 months.

The aim of the study is a double blinded comparison of complete chronic corneal ulcers healing rate within 3 months in 3 groups of patient double blinded randomized between CACICOL20 instillations distribution and physiological salt solution instillations distribution.

The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01242839
Study type Interventional
Source Organ, Tissue, Regeneration, Repair and Replacement
Contact
Status Completed
Phase N/A
Start date April 2010
Completion date June 2014
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05705024 - Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells Phase 2
Completed NCT02731638 - Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers Phase 3
Completed NCT00324168 - Steroids for Corneal Ulcers Trial Phase 4
Completed NCT04484402 - Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells Phase 1/Phase 2
Completed NCT04820010 - Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
Recruiting NCT02570321 - Cross-linking for Corneal Ulcers Treatment Trial Phase 4
Completed NCT00386958 - A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers Phase 2
Completed NCT04054817 - ACRO Biocornea Clinical Trial in Taiwan N/A
Completed NCT00997035 - The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo Phase 3
Completed NCT02277054 - Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty N/A
Recruiting NCT05313828 - Effect of Various Treatment Modalities on Dendritic Vial Ulcer
Recruiting NCT05255016 - Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory Corneal Ulcers Phase 2/Phase 3
Recruiting NCT05255107 - Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers Phase 2/Phase 3
Completed NCT05891106 - AONDA Therapeutic Indication Study I
Terminated NCT00789646 - Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients N/A
Not yet recruiting NCT05940376 - Topical Insulin in Neurotrophic Keratopathy After Diabetic Vitrectomy
Completed NCT05200000 - Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis Phase 1
Completed NCT01756456 - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. Phase 1/Phase 2
Active, not recruiting NCT01969786 - Village Integrated Eye Workers Trial N/A
Completed NCT01794312 - Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer Phase 3