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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02119039

Enrollment

Registered

2014-04-21

Start date

2014-07-31

Completion date

2015-12-31

Last updated

2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Cross-linking, RGTA OTR4120 (CACICOL20)

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.

Interventions

DEVICERGTA OTR 4120 (CACICOL20)

DEVICEGenteal HA eye drops

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Time to closure of the epithelial wound	5 days

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026