Successful management of dry eye disease with a new eye drop formulation combining hyaluronic acid, trehalose, and N-acetyl-aspartyl-glutamic acid (NAAGA).
J Fr Ophtalmol
; 47(7): 104169, 2024 Sep.
Article
em En
| MEDLINE
| ID: mdl-38838456
ABSTRACT
PURPOSE:
To assess the clinical efficacy and safety of T2769, a new preservative-free eye drop combining hyaluronic acid (HA), trehalose and N-acetyl-aspartyl-glutamic acid (NAAGA), in dry eye patients. PATIENTS ANDMETHODS:
This was a multicenter, non-comparative, open-label study. After a run-in period with NaCl 0.9% solution, 62 patients with moderate-to-severe dry eye disease (DED) were included and treated with T2769, 3 to 6 times/day for 42 days. The primary efficacy endpoint was the change in global ocular symptomatology assessed on a visual analog scale between Day 1 (D1) and D42. Other efficacy endpoints included ocular surface disease index (OSDI), soothing sensation, individual dry eye symptoms, conjunctival hyperemia, global ocular staining, tear break-up time, Schirmer test, and global efficacy assessed by the investigator. Safety was assessed throughout the study.RESULTS:
A marked reduction in ocular symptomatology was observed from D1 to D42 with a mean change of -55.9±23.1mm (P<0.001). This was accompanied by a mean change in OSDI score from baseline of -44.6±15.9 (P<0.001) and a substantial soothing sensation in 82.3% of patients. Clinically significant improvements were observed for all ocular symptoms (mainly burning/irritation, stinging/pain, feeling of ocular dryness, foreign body sensation, itching/pruritus). Conjunctival hyperemia significantly decreased in 96.8% of patients (56.5% displayed no conjunctival hyperemia at D42 versus 0% at baseline). All signs and symptoms improved by D14 and further improved at D42. Investigators assessed the ocular efficacy of T2769 as very satisfactory or satisfactory for 91.9% of patients at D42. T2769 was well tolerated, with no ocular adverse events and only a few ocular symptoms upon instillation.CONCLUSION:
Management of moderate-to-severe DED patients with the new formulation T2769, combining NAAGA to HA and trehalose, led to rapid and significant improvements in dry eye signs and symptoms with good tolerability.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Soluções Oftálmicas
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Trealose
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Síndromes do Olho Seco
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Ácido Hialurônico
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article