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

Phase 1

Active, not recruiting

• Conditions: Dry eye disease with severe keratitis; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-000982-19-ES
• Lead Sponsor: Instituto de Oftalmobiología Aplicada (IOBA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-21
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 25

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the general efficacy after 30 days (early onset of efficacy) and 90 days (known onset efficacy) of using the study treatment, by evaluation of symptoms, extensive clinical signs, and molecular/cellular biomarkers.;Secondary Objective: - To evaluate the response to 2 hr of low humidity and air flow exposure under the study treatment.<br>- To find new potential biomarkers for the therapeutic efficacy of Ikervis.;Primary end point(s): Significant reduction in corneal fluorescein staining.;Timepoint(s) of evaluation of this end point: - V1 (baseline) vs V2 (30 days of treatment).<br>- V1 (baseline) vs V3 (90 days of treatment).<br>- V2 (30 days of treatment) vs V3 (90 days of treatment).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Significant differences in the percentage of patients suffering a worsening in clinical signs and/or symptoms following exposure to adverse environmental conditions.<br>- Significant reduction in median expression of HLA-DR by conjunctival epithelial cells.;Timepoint(s) of evaluation of this end point: - V1 (baseline) vs V2 (30 días de tratamiento).<br>- V1 (baseline) vs V3 (90 días de tratamiento).