Observational Clinical Investigation Evaluating an Ophthalmic Solution Containing Xanthan Gum and Low Concentration Desonide Phosphate in Dry Eye Disease Treatment.

Autor: Aragona P; Unità Operativa Complessa (U.O.C.) di Oftalmologia, Ophthalmology Clinic, Department of Biomedical Sciences, Scuola di Specializzazione in Oftalmologia, University of Messina, Piazza Pugliatti, 1, 98122, Messina, Italy. pasquale.aragona@unime.it., Giannaccare G; Ophthalmology Residency Program Eye Clinic, University of Cagliari, Via Università, 40, 09124, Cagliari, Italy., Dammino E; Faculty of Medicine, University of Catania, Piazza Università, 95123, Catania, Italy., D'Esposito F; Imperial College Ophthalmic Research Group Unit, Imperial College, London, SW7 2AZ, UK.; Eye Clinic, Department of Neurosciences, Reproductive Sciences and Dentistry, University of Naples Federico II, 80100, Naples, Italy.; Genofta s.r.l., Sant'Agnello, 80065, Naples, Italy., Genovese P; Unità Operativa Complessa (U.O.C.) di Oftalmologia, Ophthalmology Clinic, Department of Biomedical Sciences, Scuola di Specializzazione in Oftalmologia, University of Messina, Piazza Pugliatti, 1, 98122, Messina, Italy., Postorino EI; Unità Operativa Complessa (U.O.C.) di Oftalmologia, Ophthalmology Clinic, Department of Biomedical Sciences, Scuola di Specializzazione in Oftalmologia, University of Messina, Piazza Pugliatti, 1, 98122, Messina, Italy., Civiale C; SIFI S.p.A., Via Ercole Patti 36, Aci San Antonio, 95025, Catania, Italy. claudine.civiale@sifigroup.com., Mazzone MG; SIFI S.p.A., Via Ercole Patti 36, Aci San Antonio, 95025, Catania, Italy., Gagliano C; Department of Medicine and Surgery, University of Enna 'Kore', Piazza dell'Università, 94100, Enna, Italy.; San Marco Hospital, Viale Carlo Azeglio Ciampi, 95100, Catania, Italy.
Jazyk: angličtina
Zdroj: Ophthalmology and therapy [Ophthalmol Ther] 2024 Oct; Vol. 13 (10), pp. 2559-2573. Date of Electronic Publication: 2024 Jul 26.
DOI: 10.1007/s40123-024-01003-z
Abstrakt: Introduction: Patients with dry eye disease (DED) complain of a multitude of symptoms that affect their visual function and quality of life (QoL). This clinical investigation assessed the performance, tolerance, and safety of a novel preservative-free ophthalmic solution containing xanthan gum 0.2% and desonide sodium phosphate 0.025%.
Methods: This was an observational, prospective, multicentric, and post-market clinical investigation to assess the effect of three times a day instillation of the study formulation in patients suffering from DED. The primary objective was to achieve a 50% reduction in conjunctival hyperemia index as assessed with the OCULUS Keratograph after 1 month of treatment compared to baseline values. The secondary objectives included patient-reported outcomes, clinical performance, and safety.
Results: Thirty patients were enrolled (21 women, 9 men) with a mean age of 61.10 ± 14.53 years. The instillation of the study formulation was associated with a significant reduction in redness scores after 1 month of treatment compared to baseline (mean - 0.51 ± 0.51; p ≤ 0.0001). Although the primary endpoint was not completely met, a 50% reduction in the conjunctival hyperemia index was achieved in 23% of the participants, and 77% showed a reduction of 26% of the same index. In addition, the ophthalmic solution significantly increased tear film break-up time, and a significant reduction of corneal and conjunctival staining with fluorescein was achieved. It also reduced DED symptoms and had a very good safety profile.
Conclusions: the study formulation produced a significant improvement in the signs, symptoms, and QoL of patients with mild to moderate DED with a good safety profile after 1 month of treatment.
(© 2024. The Author(s).)
Databáze: MEDLINE
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