NCT02119039

Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It consists of large biopolymers, imitating the structure of heparansulphate. The protecting effect on different biological tissues and enhancement of wound healing has been described in several studies. Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per 100,000 per year across different populations. Corneal collagen cross-linking represents a treatment option for these patients, aiming to prevent progression of the disease via stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet A/riboflavin cross-linking procedure significantly improves the outcome of the intervention, due to ameliorated distribution of riboflavin. The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial wound closure after collagen cross-linking in patients with keratoconus. Results may lead to an improved management and pain reduction of patients with corneal epithelial defects.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DEVICE	RGTA OTR 4120 (CACICOL20)
DEVICE	Genteal HA eye drops

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2014-04-21
• Last updated: 2015-12-22

Locations

1 site across 1 country: Austria