Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure in Patients With and Without Glaucoma

Conditions
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Ocular Surface Disease, Glaucoma

Intervention / Treatment
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* Drug: Hydrocortisone (CORTIVIS ®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age of at least 18 years diagnosis of OSD (Ocular Surface Disease) normal ophthalmic ﬁndings except history of OSD for at least 3 months, and current therapy with topical lubricants for at least 3 months POAG (primary open-angle glaucoma ) patients on medical therapy Exclusion Criteria: clinically signiﬁcant slit lamp ﬁndings at screening visit except OSD participation in a clinical trial in the 4 weeks preceding the screening visit symptoms of a clinically relevant illness in the 3 weeks before the screening visit presence/ history of a severe medical or surgical condition intake of parasympathomimetic or antipsychotic drugs wearing of contact lenses previous refractive laser surgery (e.g photorefractive keratectomy-PRK, laser assisted in situ keratomileusis-LASIK, etc.) history of IOP increase caused by systemic or topical treatment with corticosteroids IOP greater than 22 mmHg treatment with corticosteroids in the 4 weeks preceding the study types of glaucoma other than POAG ocular infection or clinically signiﬁcant inﬂammation ocular surgery in the 3 months preceding the study Sjögren's syndrome, Stevens-Johnson syndrome history of allergic conjunctivitis pregnancy, planned pregnancy or lactating known hypersensitivity to any component of study medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: glaucoma<br>OSD patients with glaucoma | Drug: Hydrocortisone (CORTIVIS ®)<br>* 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.<br>|
| Active Comparator: Group B: no glaucoma<br>OSD patients without glaucoma | Drug: Hydrocortisone (CORTIVIS ®)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure(IOP) | IOP evaluation at time zero (T0), after 1 (T1) and two weeks of therapy (T2). | 2 weeks | 
| OSDI (Ocular Surface Disease Index) questionnaire | OSDI record at time zero (T0), after 1 (T1) and two weeks of therapy (T2). | 2 weeks |