Cationorm / Yissum Research Development Company, Santen - LARVOL DELTA

EVALUATE THE IMPROVEMENT IN SYMPTOMS OF PATIENTS USE CATIONORM AFTER PTERYGIUM SURGERY (clinicaltrials.gov) - P4 | N=100 | Completed | Sponsor: Nguyen Viet Giap

New P4 trial • Ophthalmology

Therapeutic efficacy of two tear supplements in the management of dry eye disease in Saudi Arabia: The Twaiq Mountain Eye Study II. (PubMed, Saudi J Ophthalmol) - "Both lipid-based (CTN) and nonlipid-based Artelac Advanced®, 0.2% SH eye drops effectively improved tear volume, tear film stability, and ocular surface health. In addition, lipid-based CTN significantly decreased dry eye symptoms compared to Artelac Advanced®, 0.2% SH."

Journal • Dry Eye Disease • Ophthalmology

Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness (clinicaltrials.gov) - P=N/A | N=12 | Completed | Sponsor: Medical University of Vienna | Recruiting ➔ Completed | N=40 ➔ 12 | Trial completion date: Sep 2023 ➔ Nov 2024 | Trial primary completion date: Sep 2023 ➔ Nov 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Dry Eye Disease • Ophthalmology

PROSIKA: 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis (clinicaltrials.gov) - P=N/A | N=83 | Completed | Sponsor: Santen SAS | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2024 ➔ Apr 2025

Head-to-Head • Trial completion • Trial completion date • Trial primary completion date • Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

In vitro biophysical and biological profiling of commercial lipid-based dry eye products. (PubMed, Eur J Pharm Sci) - "Seven commercial lipid-based eye drops (Cationorm®, Desodrop®, Evotears®, Oxyal® Triple Action, PuroTM Suoja, Systane® Complete, Thealipid®) were selected for the in vitro biophysical and biological profiling studies. Clear differences in cell viability and recovery were observed, with three of the products being able to promote the recovery of damaged cells. However, the significance of our findings with regards to DED treatment outcomes will require additional studies."

Journal • Preclinical • Dry Eye Disease • Ophthalmology

PROSIKA: 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Santen SAS | Trial completion date: Oct 2023 ➔ Dec 2024 | Trial primary completion date: Oct 2023 ➔ Dec 2024

Head-to-Head • Trial completion date • Trial primary completion date • Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Harrow Licenses Canadian Rights to Apotex for Five Branded Ophthalmic Pharmaceutical Products (Businesswire) - "Harrow...and Apotex...jointly announced an exclusive out-licensing agreement under which Apotex will market and distribute VERKAZIA and over-the-counter (OTC) Cationorm PLUS in the Canadian market, and concurrently, pursue market approval in Canada for VEVYE, IHEEZO, and ZERVIATE....Under the terms of the agreement, Apotex licensed exclusive rights and marketing authorizations of the...products in the Canadian market from Harrow..."

Licensing / partnership • Conjunctivitis • Dry Eye Disease • Ophthalmology

PROSIKA: 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Santen SAS | Trial completion date: Feb 2023 ➔ Oct 2023 | Trial primary completion date: Oct 2022 ➔ Oct 2023

Head-to-Head • Trial completion date • Trial primary completion date • Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Modern possibilities of pathogenetically oriented therapy for dry eye syndrome (PubMed, Vestn Oftalmol) - "Taking into account the immunosuppressive effect of cyclosporine A, which is realized through hindering the activation of T-lymphocytes in the tissues of the ocular surface, its topical application in DES has a pronounced pathogenetic focus. According to numerous clinical studies, Ikervis instillations can improve the effectiveness of complex therapy in patients with DES (especially secondary to Sjögren syndrome, Stevens-Johnson syndrome, graft-versus-host disease), with allergic diseases of the cornea and conjunctiva (spring, atopic corneal conjunctivitis), with corneal transplant disease, and other similar conditions. The high efficacy and safety of Ikervis constitute the reason to recommend it for wide clinical use."

Journal • Allergy • Conjunctivitis • Dry Eye Disease • Graft versus Host Disease • Immunology • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • Steven-Johnson Syndrome • Transplantation

CSA2020: Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery (clinicaltrials.gov) - P1 | N=101 | Completed | Sponsor: Campus Bio-Medico University | Active, not recruiting ➔ Completed

Trial completion • Cataract • Immunology • Inflammation • Ocular Inflammation • Ophthalmology

PROSIKA: 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Santen SAS | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2022 ➔ Feb 2023 | Trial primary completion date: Apr 2022 ➔ Oct 2022

Enrollment open • Head-to-Head • Trial completion date • Trial primary completion date • Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness (clinicaltrials.gov) - P=N/A | N=40 | Recruiting | Sponsor: Medical University of Vienna | Trial completion date: Sep 2021 ➔ Sep 2023 | Trial primary completion date: Sep 2021 ➔ Sep 2023

Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

CSA2020: Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery (clinicaltrials.gov) - P1; N=101; Active, not recruiting; Sponsor: Campus Bio-Medico University; Recruiting ➔ Active, not recruiting; Trial completion date: Oct 2021 ➔ Feb 2022

Enrollment closed • Trial completion date • Cataract • Immunology • Inflammation • Ocular Inflammation • Ophthalmology

PROSIKA: 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis (clinicaltrials.gov) - P=N/A; N=80; Not yet recruiting; Sponsor: Santen SAS; Initiation date: Jun 2021 ➔ Sep 2021

Clinical • Head-to-Head • Trial initiation date • Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness (clinicaltrials.gov) - P=N/A; N=40; Recruiting; Sponsor: Medical University of Vienna; Trial completion date: Dec 2020 ➔ Sep 2021; Trial primary completion date: Dec 2020 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

PROSIKA: 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis (clinicaltrials.gov) - P=N/A; N=80; Not yet recruiting; Sponsor: Santen SAS; Trial completion date: Dec 2021 ➔ Nov 2022; Trial primary completion date: Dec 2021 ➔ Mar 2022

Clinical • Head-to-Head • Trial completion date • Trial primary completion date • Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

PROSIKA: 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis (clinicaltrials.gov) - P=N/A; N=80; Not yet recruiting; Sponsor: Santen SAS; Initiation date: Mar 2021 ➔ Jun 2021

Clinical • Head-to-Head • Trial initiation date • Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

CSA2020: Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Campus Bio-Medico University

New P1 trial • Cataract • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

PROSIKA: 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis (clinicaltrials.gov) - P=N/A; N=80; Not yet recruiting; Sponsor: Santen SAS

Clinical • Head-to-Head • New trial • Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

High-Frequency Application of Cationic Agents Containing Lubricant Eye Drops Causes Cumulative Corneal Toxicity in an Ex Vivo Eye Irritation Test Model. (PubMed, J Ocul Pharmacol Ther) - "The consistency of these predictions was previously demonstrated by the EVEIT for BAC, phosphate buffer, and others. The EVEIT is suited for a chronic application prediction of tolerability and toxic side effects of eye drops in particular, and other chemicals in general."

Journal • Preclinical • Corneal Abrasion • Ophthalmology

Short-Term Changes in Tear Lipid Layer Thickness After Instillation of Lipid Containing Eye Drops. (PubMed, Transl Vis Sci Technol) - "Our results showed that participants' initial LLT affected their responsiveness to lipid-containing eye drops more than other factors. Doctors may choose to measure the baseline LLT of patients before deciding whether to prescribe lipid eye drops to patients."

Journal • Dry Eye Disease • Ophthalmology

Efficacy and Safety of VisuEvo and Cationorm for the Treatment of Evaporative and Non-Evaporative Dry Eye Disease: A Multicenter, Double-Blind, Cross-Over, Randomized Clinical Trial. (PubMed, Clin Ophthalmol) - P=N/A | "VSE was non-inferior to CTN in restoring tear film composition, increasing its stability and reducing ocular surface damage in evaporative and non-evaporative DED patients. NCT03833882."

Clinical • Journal • Conjunctivitis • Dry Eye Disease • Glaucoma • Ophthalmology

Safety and Tolerability of Overdosed Artificial Tears by Abraded Rabbit Corneas. (PubMed, J Ocul Pharmacol Ther) - "The different ATs were demonstrated to be well tolerated by abraded corneas in vivo, and the extreme overdosing regimen did not hamper the wound healing process of the rabbit eye in comparison to saline. These data did not confirm the ones obtained with the nonvalidated ex vivo eye irritation test."

Clinical • Journal • Corneal Abrasion • Dry Eye Disease • Ophthalmology

In vitro and in vivo interactions of Cationorm nanoemulsion with tear lipid films (SOE 2017) - "In vitro and in vivo data complement each other and show that CN exerts long term effects by enhancement of TFLL clinically relevant material properties."

Biosimilar • Ophthalmology

REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye (clinicaltrials.gov) - P=N/A; N=26; Terminated; Sponsor: TRB Chemedica; N=96 ➔ 26; Trial completion date: Dec 2019 ➔ Jun 2019; Recruiting ➔ Terminated; low recruitment rate

Clinical • Enrollment change • Trial completion date • Trial termination • Dry Eye Disease • Ophthalmology