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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT02119039

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus	Device: RGTA OTR 4120 (CACICOL20) Device: Genteal HA eye drops	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RGTA OTR 4120 (CACICOL20)	Device: RGTA OTR 4120 (CACICOL20)
Active Comparator: Genteal HA	Device: Genteal HA eye drops

Arm

Intervention/Treatment

Experimental: RGTA OTR 4120 (CACICOL20)

Device: RGTA OTR 4120 (CACICOL20)

Active Comparator: Genteal HA

Device: Genteal HA eye drops

Outcome Measures

Primary Outcome Measures

Time to closure of the epithelial wound [5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katarzyna J. Witkowska, MD, PhD, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT02119039

Other Study ID Numbers:

OPHT-070214

First Posted:

Apr 21, 2014

Last Update Posted:

Dec 22, 2015

Last Verified:

Dec 1, 2015

Keywords provided by Katarzyna J. Witkowska, MD, PhD, Medical University of Vienna

Cross-linking

RGTA OTR4120 (CACICOL20)

Additional relevant MeSH terms:

Keratoconus

Ophthalmic Solutions

Study Results

No Results Posted as of Dec 22, 2015