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

Phase 4

Completed

• Conditions: Keratoconus
• Interventions: Device: RGTA OTR 4120 (CACICOL20); Device: Genteal HA eye drops

• Registration Number: NCT02119039
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-21
• Study Start: 2014-07
• Primary Completion: 2015-10
• Status Verified: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Men and women aged over 18 years
• Presence of keratoconus
• Scheduled for corneal cross linking
• No ophthalmic surgery in the 3 months preceding the study

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Exclusion Criteria

• Participation in a clinical trial in the previous 3 weeks
• Topical use of aminoglycosid antibiotics
• Use of therapeutic or refractive contact lenses after surgery
• Known hypersensitivity to any component of the study medication or heparinoids or heparin
• Active ocular infection
• Presence of any abnormalities preventing reliable measurements as judged by the investigator
• Pregnancy, planned pregnancy or lactating

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RGTA OTR 4120 (CACICOL20)	RGTA OTR 4120 (CACICOL20)	-
Genteal HA	Genteal HA eye drops	-

Primary Outcome Measures

Name	Time	Method
Time to closure of the epithelial wound	5 days

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria