Clinical trial NCT04492878: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Dry Eye Syndromes
Severe Keratitis
Lead sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Sponsor class: OTHER
Collaborators: name: Santen Oy
First posted: 2020-07-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Corneal fluoresceing staining
timeFrame: 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 outcomes:
measure: Response against adverse environmental conditions
timeFrame: V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)
measure: Molecular changes
timeFrame: V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Institute of Applied Ophthalmobiology (IOBA)
Study officials:
References: