Dry Eye Disease MedDRA version: 20.0 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Softacort 3,35 mg/ml
Product Name: Softacort
Pharmaceutical Form: Eye drops
INN or Proposed INN: HYDROCORTISONE SODIUM PHOSPHATE
Sponsors
Laboratoires Thea
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Ophthalmic exclusion criteria • Best far corrected visual acuity 22mmHg • Glaucoma in the medical history Systemic / non ophthalmic exclusion criteria: • 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 Specific exclusion criteria for women: • Pregnant or breast-feeding woman. • Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms) Exclusion criteria related to general conditions • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical efficacy of Softacort (Hydrocortisone 0.335%) in chronic dry eye patients with ocular surface inflammation using two different treatment regimes.;Secondary Objective: not applicable;Primary end point(s): Patient satisfaction assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale; Timepoint(s) of evaluation of this end point: 2 weeks after treatment initiation 4 weeks after treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Corneal fluorescein staining according to the Oxford Scale - Tear film thickness as measured with ultra-high resolution optical coherence tomography (OCT) - Tear Osmolarity (tearlab osmolarity test) - HLA-DR expression - Symptoms using the OSDI questionnaire - Patient diary for Symptoms & average frequency of artificial tears instillation for the last 3 days - Intraocular pressure (IOP) - Best corrected distance visual acuity ; Timepoint(s) of evaluation of this end point: 2 weeks after treatment initiation 4 weeks after treatment initiation | — |
Countries
Austria
Contacts
Public ContactLaboratoires Thea
Laboratoires Thea
Outcome results
None listed