Clinical trial: Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation (NCT03907865)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Contradiction