Overview

Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment

Status:
Completed
Trial end date:
2021-01-18
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborator:
Santen Oy
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.