Glaucoma Clinical Trial
Official title:
Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure in Patients With and Without Glaucoma
Verified date | September 2021 |
Source | University of Molise |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluation of the safety and efficacy of hydrocortisone eye drops in the treatment of OSD (ocular surface disease) patients with and without glaucoma.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | University of Molise | Campobasso |
Lead Sponsor | Collaborator |
---|---|
University of Molise | Medivis |
Italy,
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
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 |
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