Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment

NCT04492878 | Completed Phase 4

• 1 other identifier: IOBA-ImmunEyez_011-2018
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Dry Eye Syndromes; Severe Keratitis

Outcome Measures

Primary Outcomes (1)

• Corneal fluoresceing staining

  Significant reduction in corneal fluorescein 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)

Secondary Outcomes (2)

• Response against adverse environmental conditions

  V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)

• Molecular changes

  V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment)

Study Arms (1)

IKERVIS® (1mg/mL ciclosporin) eye drops

EXPERIMENTAL

Drug: IKERVIS®1mg/mL

Interventions

IKERVIS®1mg/mL DRUG

One drop of study medication once daily in each eye at bedtime during 90 days.

IKERVIS® (1mg/mL ciclosporin) eye drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known allergy or sensitivity to the study product(s) or its components.
• Any ocular pathology other than DED.
• 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.
• 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.

Sponsors & Collaborators

• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA: lead
• Santen Oy: collaborator

Study Sites (1)

Institute of Applied Ophthalmobiology (IOBA)

Valladolid, 47011, Spain

Location

Related Publications (1)

• Valencia-Nieto L, Pinto-Fraga J, Blanco-Vazquez M, Fernandez I, Lopez-Miguel A, Garcia-Vazquez C, Gonzalez-Garcia MJ, Enriquez-de-Salamanca A, Calonge M. Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment. Ophthalmol Ther. 2024 May;13(5):1197-1210. doi: 10.1007/s40123-024-00906-1. Epub 2024 Mar 6.

  PMID: 38446281 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Keratitis

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Corneal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: February 4, 2020
• Primary Completion: January 18, 2021
• Study Completion: January 18, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)