Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure
Condition: Ocular Surface Disease; Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Evaluation of the safety and efficacy of hydrocortisone eye drops in the treatment of OSD
      (ocular surface disease) patients with and without glaucoma.
    

Detailed description: 
      The ocular surface comprises the cornea, conjunctiva, eyelids and lacrimal glands and any
      disorder in these structures can be classified as an ocular surface disorder (OSD). OSD
      includes Dry Eye Disease (DED), blepharitis and meibomian gland dysfunction (MDG), allergic
      eye diseases (AED), chemical and thermal burns; all these conditions can severely affect
      eyesight and quality of life, and sometime even blindness. Patients with OSD can develop
      photophobia, corneal scarring, intermittent blurred vision, pain, limited ability to perform
      daily activities, reduced vitality, poor general health and, in many cases, depression.

      Glaucoma, one of the leading causes of irreversible blindness, is an optic neuropathy
      characterized by thinning of retinal nerve fiber layer and increase of optic disc cupping ,
      whose main risk factor is closely related to the intraocular pressure (IOP) levels. Thus, the
      management of the disease consists in the lowering IOP through medical, laser or surgical
      therapy . However, IOP reduction is most commonly achieved using topical ocular medications,
      which often contain preservatives employed to maintain stability and sterility of the
      product. Preservatives can be associated with undesirable adverse effects such as allergy,
      local irritation and inflammation . The long-term use of anti-glaucoma medications produces
      several alterations of ocular surface components, especially at the conjunctival level where
      epithelial modifications, dendritic cell activation, conjunctiva-associated lymphoid tissue
      activation, and goblet cell (GCs) loss easily occur GCs play crucial tasks in the homeostasis
      of the ocular surface being the main source of mucoproteins, essential to maintain tear film
      stability. Thus, the loss of GCs progressively leads to the happening of an iatrogenic OSD .
      Moreover, advancing age is a significant risk factor for both OSD and glaucoma, further
      complicated by treatments for each condition, which can interact among them and yield
      counterproductive effects . For these reason glaucoma is often associated with OSD .Ocular
      surface inflammation is crucial in the pathophysiology of OSD, therefore anti-inflammatory
      therapy, including corticosteroids, may be of benefit to OSD patients . However, in
      susceptible individuals steroid-induced glaucoma or ocular hypertension can occur after
      steroid use. Individuals who develop an increase in IOP following steroid use are referred to
      as "steroid responders" . In a recent study Kallab et al. have found that dry eye treatment
      with low hydrocortisone dose reduced ocular inﬂammation without inducing increases in IOP ;
      glaucomatous patients were excluded from this study. Herein we evaluate the safety and
      efficacy of hydrocortisone eye drops in the treatment of OSD patients with and without
      glaucoma.
    

Intervention name(s): Hydrocortisone (CORTIVIS ®)
Intervention type(s): Drug
Intervention description(s): Once enrolled all the patients had to instill topical low dose (1,005 mg) preservative-free hydrocortisone (CORTIVIS ®- Medivis, Catania, Italy) 2 times daily in each eye for two weeks.
Intervention MeSH terms: Hydrocortisone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment