RESUMO
Purpose: To evaluate the efficacy of a preservative free sodium hyaluronate/chondroitin sulfate ophthalmic solution (SH/CS-PF) in patients with dry eye disease (DED).Methods: This was a randomized phase IV, multicentric, prospective, double-blind clinical trial. Intent-to-treat (ITT) and per-protocol (PP) analyses were performed. Patients were assigned to receive either SH/CS-PF, Systane® Ultra (PEG/PG) or Systane® Ultra PF (PEG/PG-PF) for 90 days. A total of 326 patients were included in the ITT, and 217 in the PP analysis. Efficacy endpoints were goblet cell density, Nelson's grades (conjunctival impression cytology), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), and Schirmer's test. Other parameters included were tolerability, measured by the ocular symptomatology; and safety, measured through corneal staining, intraocular pressure, visual acuity and adverse events.Results: In the ITT, there was a significant increase in mean goblet cell density in all treatments compared with their baseline (28.4% vs 21.4% and 30.8%), without difference between arms (p = .159). Eyes exposed to SH/CS-PF, PEG/PG and PEG/PG-PF showed Grade 0-I squamous metaplasia (85.5%, 87.9% and 93.2%, respectively). Similar improvements were observed for TBUT (1.24 ± 2.3s vs 1.27 ± 2.4s and 1.39 ± 2.3s) and OSDI scores at day 90 (-8.81 ± 8.6 vs -7.95 ± 9.2 and -8.78 ± 9.8), although no significant intergroup difference was found. Schirmer's test also presented improvement compared to baseline (1.38 ± 4.9 vs 1.50 ± 4.7 and 2.63 ± 5.9), with a significantly higher variation for PEG/PG-PF. There were no significant differences between treatments for any tolerability and safety parameter, nor between ITT and PP analyses for any outcome.Conclusions: The topical application of SH/CS-PF is as effective, safe and well tolerated as that of PEG/PG or PEG/PG-PF. The results suggest that SH/CS-PF may lead to normalization of clinical parameters and symptom alleviation in patients treated for DED.
Assuntos
Sulfatos de Condroitina/administração & dosagem , Síndromes do Olho Seco/tratamento farmacológico , Ácido Hialurônico/administração & dosagem , Administração Oftálmica , Adulto , Idoso , Idoso de 80 Anos ou mais , Sulfatos de Condroitina/efeitos adversos , Método Duplo-Cego , Combinação de Medicamentos , Síndromes do Olho Seco/fisiopatologia , Feminino , Fluorofotometria , Humanos , Ácido Hialurônico/efeitos adversos , Pressão Intraocular/fisiologia , Masculino , Pessoa de Meia-Idade , Soluções Oftálmicas , Conservantes Farmacêuticos , Estudos Prospectivos , Lágrimas/fisiologia , Resultado do Tratamento , Acuidade Visual/fisiologia , Adulto JovemRESUMO
ABSTRACT: Ocular lubricants are used to supplement one or more layers of the lacrimal film. They are often prescribed to treat keratoconjunctivitis sicca (KCS) and other diseases of ocular surface in humans. These lubricants may also protect the ocular surface and promote epithelial regeneration. The active component of ocular lubricants is the lubricating agent. The key properties of different lubricating agents are the electrolyte composition, osmolarity, and addition of preservatives. Although lacrimomimetics are not typically used to treat KCS in dogs, they can be used as an adjunctive therapy. Knowledge of the properties of lacrimomimetics will help in making the appropriate therapeutic choice.
RESUMO: Lubrificantes oculares são usados como suplementos de uma ou mais camadas do filme lacrimal. São frequentemente prescritos para o tratamento da ceratoconjuntivite seca (CCS) no homem e em outras afecções da superfície ocular. Seu uso também pode gerar proteção da superfície ocular e promover regeneração epitelial. Os principais componentes de sua formulação são os agentes lubrificantes e as principais propriedades são a composição eletrolítica, a osmolaridade e a presença de conservantes. Embora lacrimomiméticos não sejam o tratamento da CCS em cães, eles podem ser utilizados como terapia adjuvante. O conhecimento de suas propriedades auxiliará na melhor opção terapêutica.
RESUMO
Ocular lubricants are used to supplement one or more layers of the lacrimal film. They are often prescribed to treat keratoconjunctivitis sicca (KCS) and other diseases of ocular surface in humans. These lubricants may also protect the ocular surface and promote epithelial regeneration. The active component of ocular lubricants is the lubricating agent. The key properties of different lubricating agents are the electrolyte composition, osmolarity, and addition of preservatives. Although lacrimomimetics are not typically used to treat KCS in dogs, they can be used as an adjunctive therapy. Knowledge of the properties of lacrimomimetics will help in making the appropriate therapeutic choice.(AU)
Lubrificantes oculares são usados como suplementos de uma ou mais camadas do filme lacrimal. São frequentemente prescritos para o tratamento da ceratoconjuntivite seca (CCS) no homem e em outras afecções da superfície ocular. Seu uso também pode gerar proteção da superfície ocular e promover regeneração epitelial. Os principais componentes de sua formulação são os agentes lubrificantes e as principais propriedades são a composição eletrolítica, a osmolaridade e a presença de conservantes. Embora lacrimomiméticos não sejam o tratamento da CCS em cães, eles podem ser utilizados como terapia adjuvante. O conhecimento de suas propriedades auxiliará na melhor opção terapêutica.(AU)