MedTrace Logo

Cacicol20® in Corneal Wound Healing and Nerve Regeneration After Phototherapeutic Keratectomy

NCT02373397 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-03-11

No results posted yet for this study

Summary

The objective of this clinical study is to test the efficacy of CACICOL20® (RGTA OTR 4120) in improving wound healing and nerve regeneration in the anterior cornea, in a patient population undergoing therapeutic laser treatment for corneal dystrophy or recurrent corneal erosions.

Conditions

  • Corneal Dystrophy, Epithelial Basement Membrane
  • Epithelial Recurrent Erosion Dystrophy
  • Corneal Erosions

Interventions

DEVICE

Cacicol20

Investigational device, regenerating agent, single-use doses, topical eye drops. Indicated for corneal wound healing.

DEVICE

Placebo

Vehicle only in identical packaging, with identical dosage and administration route.

Sponsors & Collaborators

  • Region Östergötland

    collaborator OTHER

  • Linkoeping University

    collaborator OTHER_GOV

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Laboratoires Thea

    collaborator INDUSTRY

  • Neil Lagali

    lead OTHER

Principal Investigators

  • Sven Jarkman, MD PhD · Region Östergötland

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02373397 on ClinicalTrials.gov