Status:
COMPLETED
Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment
Lead Sponsor:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborating Sponsors:
Santen Oy
Conditions:
Dry Eye
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 mo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04492878
Start Date
February 4 2020
End Date
January 18 2021
Last Update
April 21 2021
Active Locations (1)
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1
Institute of Applied Ophthalmobiology (IOBA)
Valladolid, Spain, 47011