Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04536129
Other study ID # CTS 11/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2019
Est. completion date March 4, 2020

Study information

Verified date September 2021
Source University of Molise
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 4, 2020
Est. primary completion date March 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - age of at least 18 years - diagnosis of OSD (Ocular Surface Disease) - normal ophthalmic ?ndings 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 signi?cant slit lamp ?ndings 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 signi?cant in?ammation - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hydrocortisone (CORTIVIS ®)
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.

Locations

Country Name City State
Italy University of Molise Campobasso

Sponsors (2)

Lead Sponsor Collaborator
University of Molise Medivis

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Craig JP, Nelson JD, Azar DT, Belmonte C, Bron AJ, Chauhan SK, de Paiva CS, Gomes JAP, Hammitt KM, Jones L, Nichols JJ, Nichols KK, Novack GD, Stapleton FJ, Willcox MDP, Wolffsohn JS, Sullivan DA. TFOS DEWS II Report Executive Summary. Ocul Surf. 2017 Oct — View Citation

Kallab M, Szegedi S, Hommer N, Stegmann H, Kaya S, Werkmeister RM, Schmidl D, Schmetterer L, Garhöfer G. Correction to: Topical Low Dose Preservative-Free Hydrocortisone Reduces Signs and Symptoms in Patients with Chronic Dry Eye: A Randomized Clinical Tr — View Citation

Khanna RC. Ocular surface disorders. Community Eye Health. 2017;30(99):S1-S2. — View Citation

Lanza M, Gironi Carnevale UA, Mele L, Bifani Sconocchia M, Bartollino S, Costagliola C. Morphological and Functional Evaluation of Oral Citicoline Therapy in Chronic Open-Angle Glaucoma Patients: A Pilot Study With a 2-Year Follow-Up. Front Pharmacol. 201 — View Citation

Mohammed I, Kulkarni B, Faraj LA, Abbas A, Dua HS, King AJ. Profiling ocular surface responses to preserved and non-preserved topical glaucoma medications: A 2-year randomized evaluation study. Clin Exp Ophthalmol. 2020 Sep;48(7):973-982. doi: 10.1111/ceo — View Citation

Rossi GC, Pasinetti GM, Scudeller L, Bianchi PE. Ocular surface disease and glaucoma: how to evaluate impact on quality of life. J Ocul Pharmacol Ther. 2013 May;29(4):390-4. doi: 10.1089/jop.2011.0159. Epub 2012 Dec 7. — View Citation

Rossi GC, Pasinetti GM, Scudeller L, Raimondi M, Lanteri S, Bianchi PE. Risk factors to develop ocular surface disease in treated glaucoma or ocular hypertension patients. Eur J Ophthalmol. 2013 May-Jun;23(3):296-302. doi: 10.5301/ejo.5000220. Epub 2012 D — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intraocular pressure(IOP) IOP evaluation at time zero (T0), after 1 (T1) and two weeks of therapy (T2). 2 weeks
Primary OSDI (Ocular Surface Disease Index) questionnaire OSDI record at time zero (T0), after 1 (T1) and two weeks of therapy (T2). 2 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT06000865 - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE N/A
Recruiting NCT06278597 - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03274024 - The Asia Primary Tube Versus Trab (TVT) Study N/A
Completed NCT04552964 - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma N/A
Recruiting NCT01957267 - Functional and Structural Imaging for Glaucoma
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Completed NCT04020705 - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma N/A
Completed NCT03150160 - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma Phase 4
Not yet recruiting NCT05581498 - Glaucoma Exercise as Medicine Study (GEMS). N/A
Recruiting NCT02921568 - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes N/A
Active, not recruiting NCT02901730 - Clinical Study of LPI With Different Laser Wavelengths N/A
Completed NCT02955849 - A Trial of China Laser and Surgery Study Glaucoma in Rural China Early Phase 1
Recruiting NCT02554214 - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device N/A
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Active, not recruiting NCT02390284 - Stop Retinal Ganglion Cell Dysfunction Study Phase 3
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02653963 - Triamcinolone for Ahmed Glaucoma Valve N/A
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02520674 - Glaucoma Screening With Smartphone Ophthalmology N/A