Efficacy and Safety of Sodium Hyaluronate/chondroitin Sulfate Preservative-free Ophthalmic Solution in the Treatment of Dry Eye: A Clinical Trial
| Autor: | Belalcázar-Rey, Sandra, Sánchez-Huerta, Valeria, Ochoa-Tabares, Juan, Altamirano-Vallejo, Samuel, Soto-Gómez, Abraham, Suárez-Velasco, Rubén, García-Félix, Filiberto, Baiza-Durán, Leopoldo, Olvera-Montaño, Oscar, Muñoz-Villegas, Patricia |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty genetic structures Sodium hyaluronate Visual Acuity Administration Ophthalmic Ocular surface disease Fluorophotometry Young Adult 03 medical and health sciences Cellular and Molecular Neuroscience chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Ophthalmology Humans Medicine In patient Prospective Studies Dry eye disease Chondroitin sulfate Preservative free Hyaluronic Acid Intraocular Pressure Aged Aged 80 and over business.industry Chondroitin Sulfates Preservatives Pharmaceutical Middle Aged Artificial tears Clinical Trial eye diseases Sensory Systems Clinical trial Drug Combinations Treatment Outcome chemistry Tears 030221 ophthalmology & optometry Dry Eye Syndromes Female Ophthalmic Solutions business Ocular surface 030217 neurology & neurosurgery |
| Zdroj: | Current Eye Research. 46:919-929 |
| ISSN: | 1460-2202 0271-3683 |
| DOI: | 10.1080/02713683.2020.1849733 |
| Popis: | Purpose: The present study was designed to evaluate the efficacy and safety of sodium hyaluronate/chondroitin sulfate, preservative-free ophthalmic solution (SH/CS-PF) in patients with mild-moderate dry eye disease (DED). Methods: This was a randomized phase IV, multicenter, prospective, double-blind, clinical trial. A total of 217 subjects were randomized (1:1:1) and completed the study. Subjects were assigned to receive either SH/CS-PF (n=72), PEG/PG (n=64) or PEG/PG-PF (n=81). Subjects instilled a drop four times a day (QID) for 90 days. The primary efficacy endpoints were conjunctival goblet cell density, Nelson’s grades, fluorescein tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), and, Schirmer’s test. The tolerability was measured by the ocular symptomatology, and safety was assayed by corneal staining, intraocular pressure (IOP), visual acuity (VA) and adverse events (AE). |
| Databáze: | OpenAIRE |
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