NCT02119039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

March 21, 2014

Last Update Submit

December 21, 2015

Conditions

Keratoconus

Keywords

Cross-linkingRGTA OTR4120 (CACICOL20)

Outcome Measures

Primary Outcomes (1)

  • Time to closure of the epithelial wound

    5 days

Study Arms (2)

RGTA OTR 4120 (CACICOL20)

EXPERIMENTAL
Device: RGTA OTR 4120 (CACICOL20)

Genteal HA

ACTIVE COMPARATOR
Device: Genteal HA eye drops

Interventions

RGTA OTR 4120 (CACICOL20)DEVICE
RGTA OTR 4120 (CACICOL20)
Genteal HA eye dropsDEVICE
Genteal HA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Bata AM, Witkowska KJ, Wozniak PA, Fondi K, Schmidinger G, Pircher N, Szegedi S, Aranha Dos Santos V, Pantalon A, Werkmeister RM, Garhofer G, Schmetterer L, Schmidl D. Effect of a Matrix Therapy Agent on Corneal Epithelial Healing After Standard Collagen Cross-linking in Patients With Keratoconus: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1169-1176. doi: 10.1001/jamaophthalmol.2016.3019.

    PMID: 27584715DERIVED

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 21, 2014

First Posted

April 21, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

AU(1)