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

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Keratoconus

Treatments: Device: Genteal HA eye drops; Device: RGTA OTR 4120 (CACICOL20)

Study type: Interventional

Funder types: Other

Identifiers

NCT02119039

OPHT-070214

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 2 patient groups

RGTA OTR 4120 (CACICOL20)

Experimental group

Treatment:

Device: RGTA OTR 4120 (CACICOL20)

Genteal HA

Active Comparator group

Treatment:

Device: Genteal HA eye drops