Effect of topical hydrocortisone 0.335% (Softacort®) on ocular surface inflammation in patients with dry eye

Phase 1

• Conditions: Dry Eye Disease; MedDRA version: 20.0 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-003285-27-AT
• Lead Sponsor: aboratoires Thea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-16
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

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

Ophthalmic exclusion criteria
•Best far corrected visual acuity < 1/10
•Severe Dry Eye associated with:
-Eyelid malposition
-Sjogren Syndrome
-Stevens 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
•Isotretinoïde,
•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
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br> Timepoint(s) of evaluation of this end point: 2 weeks after treatment initiation<br> 4 weeks after treatment initiation<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): -Corneal fluorescein staining according to the Oxford Scale<br> -Tear film thickness as measured with ultra-high resolution optical coherence tomography (OCT)<br> -Tear Osmolarity (tearlab osmolarity test)<br> -HLA-DR expression<br> -Symptoms using the OSDI questionnaire<br> -Patient diary for Symptoms & average frequency of artificial tears instillation for the last 3 days<br> -Intraocular pressure (IOP)<br> -Best corrected distance visual acuity<br> ;<br> Timepoint(s) of evaluation of this end point: 2 weeks after treatment initiation<br> 4 weeks after treatment initiation<br>