Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04536129
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2020-08-27
Brief Title:
Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure
Sponsor:
University of Molise
Organization:
University of Molise
Study Overview
Official Title:
Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure in Patients With and Without Glaucoma
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None