Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment

Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA (Other)
Overall Status
Completed
CT.gov ID
NCT04492878
Collaborator
Santen Oy (Industry)
25
1
1
11.5
2.2

Study Details

Study Description

Brief Summary

The proposed study is a prospective, open-label, unicentric, phase IV clinical trial.

This study is design to find new efficacy biomarkers for IKERVIS® (1mg/mL ciclosporin) eye drops after 1 and 3 month after initiation of therapy. Additionally, this study intends to investigate whether IKERVIS® will help patients to better overcome situations of desiccating stress by exposing them to an adverse controlled environment (ACE) and analyzing both clinical and molecular parameters.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Group AssignmentSingle Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IV Open-Label Clinical Trial to Evaluate the Efficacy of Ikervis® on Clinical Parameters and Molecular/Cellular Biomarkers in Dry Eye Patients With Severe Keratitis Who Have Not Improved Despite Regular Use of Tear Substitutes Before and After Exposure to an Adverse Controlled Environment
Actual Study Start Date :
Feb 4, 2020
Actual Primary Completion Date :
Jan 18, 2021
Actual Study Completion Date :
Jan 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: IKERVIS® (1mg/mL ciclosporin) eye drops

Drug: IKERVIS®1mg/mL
One drop of study medication once daily in each eye at bedtime during 90 days.

Outcome Measures

Primary Outcome Measures

  1. Corneal fluoresceing staining [V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment); V2 (30 days of treatment) vs V3 (90 days of treatment)]

    Significant reduction in corneal fluorescein staining

Secondary Outcome Measures

  1. Response against adverse environmental conditions [V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)]

    Significant differences in the percentage of patients suffering a worsening in clinical signs and/or symptoms following exposure to adverse environmental conditions

  2. Molecular changes [V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)]

    Significant reduction in median expression of HLA-DR by conjunctival epithelial cells.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age > 18 years.

  • Diagnosis of DED with Severe Keratitis who have not improved despite regular use of tear substitutes by an ophthalmologist, at least 2 months previously.

  • Not stable (as defined by the two items below) under at least 2 months of constant and regular use of artificial tears (at least 4 drops a day)

  • Fluorescein corneal staining ≥ 2 (Oxford scale) in both eyes.

  • DEQ-5 > 6 points

  • Use of at least 4 times daily of an ocular artificial tears.

  • Any concomitant medication that may affect DED, ocular surface condition or vision, must have a start date at least 3 months prior to baseline and dosage is not expected to change during the study.

  • Best corrected visual acuity (BCVA) of at least 0.1 logMar at 6 meters with each eye.

  • Signature of written informed consent form and data protection form.

Exclusion Criteria:
  • Known allergy or sensitivity to the study product(s) or its components.

  • Any ocular pathology other than DED.

  • History of severe ocular inflammation other than that due to DED or infection in the 6 previous months to the study inclusion.

  • Any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution in the 6 previous months or any ocular or systemic surgery or procedure planned during the study duration that may affect the study as assessed by principal investigator.

  • History of refractive surgery in the previous 18 months.

  • Contact lens use in the ONE previous month to study inclusion and during the duration of the study.

  • Use of any ocular topical medication for pathologies other than DED.

  • Use of any other ocular topical medication for DED other than artificial tears during the last ONE (steroids) or THREE months (ciclosporine, tacrolimus) .

  • Any uncontrolled severe systemic disease that may affect the eye (except for Sjögren's syndrome)

  • The start date of any systemic medication that may affect DED, ocular surface condition or vision is < 3 months prior to baseline or a change in dosage is anticipated during the study.

  • Occlusion of the lacrimal puncta either surgically or with plugs within one month prior to study, or anticipated use of the same during the study.

  • Pregnancy or breastfeeding.

  • Current enrolments in an investigational drug or device study or participation in such a study within 30 day of entry into this study at baseline.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Applied Ophthalmobiology (IOBA) Valladolid Spain 47011

Sponsors and Collaborators

  • Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
  • Santen Oy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
ClinicalTrials.gov Identifier:
NCT04492878
Other Study ID Numbers:
  • IOBA-ImmunEyez_011-2018
First Posted:
Jul 30, 2020
Last Update Posted:
Apr 21, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2021