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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119039
• Other study ID #: OPHT-070214
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2014
• Last updated: December 21, 2015
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Device:
• RGTA OTR 4120 (CACICOL20)

• Genteal HA eye drops

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to closure of the epithelial wound		5 days	No