Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IKERVIS® (1mg/mL ciclosporin) eye drops
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Drug: IKERVIS®1mg/mL
One drop of study medication once daily in each eye at bedtime during 90 days.
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Outcome Measures
Primary Outcome Measures
- Corneal fluoresceing staining [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)]
Significant reduction in corneal fluorescein staining
Secondary Outcome Measures
- Response against adverse environmental conditions [V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)]
Significant differences in the percentage of patients suffering a worsening in clinical signs and/or symptoms following exposure to adverse environmental conditions
- Molecular changes [V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)]
Significant reduction in median expression of HLA-DR by conjunctival epithelial cells.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years.
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Diagnosis of DED with Severe Keratitis who have not improved despite regular use of tear substitutes by an ophthalmologist, at least 2 months previously.
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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)
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Fluorescein corneal staining ≥ 2 (Oxford scale) in both eyes.
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DEQ-5 > 6 points
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Use of at least 4 times daily of an ocular artificial tears.
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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.
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Best corrected visual acuity (BCVA) of at least 0.1 logMar at 6 meters with each eye.
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Signature of written informed consent form and data protection form.
Exclusion Criteria:
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Known allergy or sensitivity to the study product(s) or its components.
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Any ocular pathology other than DED.
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History of severe ocular inflammation other than that due to DED or infection in the 6 previous months to the study inclusion.
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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.
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History of refractive surgery in the previous 18 months.
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Contact lens use in the ONE previous month to study inclusion and during the duration of the study.
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Use of any ocular topical medication for pathologies other than DED.
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Use of any other ocular topical medication for DED other than artificial tears during the last ONE (steroids) or THREE months (ciclosporine, tacrolimus) .
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Any uncontrolled severe systemic disease that may affect the eye (except for Sjögren's syndrome)
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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.
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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.
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Pregnancy or breastfeeding.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Institute of Applied Ophthalmobiology (IOBA) | Valladolid | Spain | 47011 |
Sponsors and Collaborators
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Santen Oy
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IOBA-ImmunEyez_011-2018