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
Sponsor study identifier
interventional
25
1 country
1
Study Start
February 4, 2020
Actual (reported)Primary Completion
January 18, 2021
Actual (reported)Study Completion
January 18, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 18, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 4, 2020
Actual (reported)July 27, 2020
Actual (reported)July 30, 2020
Actual (reported)January 18, 2021
Actual (reported)January 18, 2021
Actual (reported)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)
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)
One drop of study medication once daily in each eye at bedtime during 90 days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Institute of Applied Ophthalmobiology (IOBA)
Valladolid, 47011, Spain
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.
25 participants (actual enrollment reported by the registry).
First Submitted
July 27, 2020
First Posted
July 30, 2020
Study Start
February 4, 2020
Actual (reported)Randomized clinical trial to evaluate the use of PRGF eye drops in patients with dry eye disease
Contact the study team to confirm eligibility.
Primary Completion
January 18, 2021
Actual (reported)Study Completion
January 18, 2021
Actual (reported)Last Updated
April 21, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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