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Completed

NCT Number: NCT02119039

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

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RGTA OTR 4120 (CACICOL20)

Device

Genteal HA eye drops

Device

Primary outcomes

  1. Time to closure of the epithelial wound

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2014
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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