Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation

Launched by MEDICAL UNIVERSITY OF VIENNA · Apr 5, 2019

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Age ≥ 18 years
• • Normal ophthalmic findings except dry eye disease
• • Ametropy ≤ 6 diopters
• • Chronic dry eye defined as longer than six months since diagnosis
• • OSDI ≥ 22
• • Conjunctival Hyperemia ≥ Grade 3 (Efron Scale)
• • Current use of topical lubricants since at least 3 months
• Exclusion criteria:
• • Best far corrected visual acuity \< 1/10
• * Severe Dry Eye associated with:
• • Eyelid malposition
• • Sjogren Syndrome
• • Steven Johnson Syndrome
• • Corneal dystrophy
• • Ocular neoplasia
• • Filamentous keratitis
• • Corneal neovascularisation
• • Orbital radiotherapy
• * History of any of the following within last 3 months:
• • Systemic treatment of dry eye
• • Systemic treatment of MGD
• • Isotretinoide,
• • Cyclosporine,
• • Tacrolimus, Siromilus, Pimecrolimus
• • Punctual plugs
• • Anti-glaucoma treatment
• * History of any of the following within previous six months:
• • ocular trauma
• • ocular infection, ocular allergy
• * History of any of the following within last 12 months:
• • inflammatory corneal ulcer
• • Herpetic eye infection or uveitis
• • Ocular surgery
• • History of IOP increase caused by systemic or topical treatment with corticosteroids
• • IOP \> 22mmHg
• • Glaucoma in the medical history
• • Known hypersensitivity to any of the components of the IMP under investigation or other study medication
• • Allergic rhinitis; active or susceptible to reactivation during the study
• • Pregnant or breast-feeding woman.
• • Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intrauterine device, contraceptive implant or condoms)
• • Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.
• • Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
• • Participation in another clinical study or clinical investigation at the same time as the present investigation
• • Participation to the present clinical investigation during the exclusion period of another clinical study
• • Patient already included once in this clinical investigation
• • Patient under guardianship