search
Back to results

Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment

Primary Purpose

Dry Eye, Dry Eye Syndromes, Severe Keratitis

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
IKERVIS®1mg/mL
Sponsored by
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Applied Ophthalmobiology (IOBA)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IKERVIS® (1mg/mL ciclosporin) eye drops

Arm Description

Outcomes

Primary Outcome Measures

Corneal fluoresceing staining
Significant reduction in corneal fluorescein staining

Secondary Outcome Measures

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

Full Information

First Posted
July 27, 2020
Last Updated
April 20, 2021
Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborators
Santen Oy
search

1. Study Identification

Unique Protocol Identification Number
NCT04492878
Brief Title
Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
January 18, 2021 (Actual)
Study Completion Date
January 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborators
Santen Oy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye Syndromes, Severe Keratitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IKERVIS® (1mg/mL ciclosporin) eye drops
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IKERVIS®1mg/mL
Intervention Description
One drop of study medication once daily in each eye at bedtime during 90 days.
Primary Outcome Measure Information:
Title
Corneal fluoresceing staining
Description
Significant reduction in corneal fluorescein staining
Time Frame
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 Measure Information:
Title
Response against adverse environmental conditions
Description
Significant differences in the percentage of patients suffering a worsening in clinical signs and/or symptoms following exposure to adverse environmental conditions
Time Frame
V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)
Title
Molecular changes
Description
Significant reduction in median expression of HLA-DR by conjunctival epithelial cells.
Time Frame
V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institute of Applied Ophthalmobiology (IOBA)
City
Valladolid
ZIP/Postal Code
47011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment

We'll reach out to this number within 24 hrs