Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Dry Eye Syndromes; Severe Keratitis
• Intervention / Treatment: Drug: IKERVIS®1mg/mL

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47011
    • Institute of Applied Ophthalmobiology (IOBA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal fluoresceing staining	Significant reduction in corneal fluorescein 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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response against adverse environmental conditions	Significant differences in the percentage of patients suffering a worsening in clinical signs and/or symptoms following exposure to adverse environmental conditions	V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)
Molecular changes	Significant reduction in median expression of HLA-DR by conjunctival epithelial cells.	V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Actual): January 18, 2021
• Study Completion (Actual): January 18, 2021

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratitis
• Other Study ID Numbers: IOBA-ImmunEyez_011-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No