Alotaibi Wafa M, Abusharha Ali, Pearce E Ian, Althomali Mohammed, Afsar Tayyaba, Razak Suhail
Department of Optometry, College of Applied Medical Sciences, King Saud University, Riyadh, 11433, Saudi Arabia.
Glasgow Caledonian University, Glasgow, G4 0BA, UK.
Clin Ophthalmol. 2024 Nov 28;18:3503-3513. doi: 10.2147/OPTH.S493336. eCollection 2024.
The enhancement of ocular drug delivery is achieved by using biopolymer carriers in liquid ophthalmic preparations. Using natural polysaccharides to formulate ocular medications is attractive because they are economical and readily available. The primary goal of the study was to assess the safety and effectiveness of Tamarind seed polysaccharide (TSP)/Hyaluronic acid (HA) containing Rohto eye drops (TSP/HA drops) in alleviating the signs and symptoms of dry eye disease (DED) under dry environmental conditions using controlled environmental chamber (CEC).
12 participants were subjected to harsh environmental conditions in a CEC with a relative humidity (RH) of 5% and an ambient temperature of 21°C. TSP/HA drops were used in the two treatment modalities, protection (drops instilled before exposure to the dry environment and relief (drops instilled after exposure to the dry environment. Before and after administering drops, patients undergo screening for ocular symptoms, tear osmolarity, ocular surface temperature (OST), and tear production using the ocular Surface Disease Index questionnaire (OSDI), OcuSense TearLab Osmometer, FLIR System ThermaCAM P620, and phenol red test (PRT) respectively. Tear production was calculated by the Tear Function Index test (TFI).
Before (protection) and after (relief) exposure to the dry environment, TSP/HA resulted in a mean tear osmolarity of 296.0 mOsm/L and 292.0 mOsm/L, with no significant statistical difference. The presence of TSP/HA in both protection and relief modes led to an increase in tear production. TSP/HA drops did not significantly affect OST compared to the absence of TSP/HA drops at 5% RH. There was a significant increase in mean symptom score from 14 at 40% RH to 128 at 5% RH (p=0.003). A substantial reduction in symptoms was found in both protection (before exposure) (35) (p=0.003) and relief (after exposure) (50) (p=0.005) compared to when no drop was used.
It was apparent that using TSP/HA for protection was superior to relief for osmolarity and eye comfort. To optimise the therapeutic efficacy of TSP/HA, it is advisable to instruct patients to administer it before exposure to dry atmospheric conditions. The small sample size limits the ability to generalize the findings. Future studies should evaluate the tear supplement with a larger sample to improve statistical power.
在液体眼科制剂中使用生物聚合物载体可实现眼部药物递送的增强。使用天然多糖来配制眼部药物很有吸引力,因为它们经济且易于获得。本研究的主要目标是在可控环境舱(CEC)中评估含有参天眼药水(罗托眼药水)的罗望子种子多糖(TSP)/透明质酸(HA)(TSP/HA眼药水)在干燥环境条件下缓解干眼病(DED)体征和症状的安全性和有效性。
12名参与者在相对湿度(RH)为5%、环境温度为21°C的CEC中经受恶劣环境条件。TSP/HA眼药水用于两种治疗方式,即防护(在暴露于干燥环境之前滴入眼药水)和缓解(在暴露于干燥环境之后滴入眼药水)。在滴入眼药水之前和之后,患者分别使用眼表疾病指数问卷(OSDI)、OcuSense TearLab渗透压计、FLIR系统ThermaCAM P620和酚红试验(PRT)进行眼部症状、泪液渗透压、眼表温度(OST)和泪液分泌的筛查。泪液分泌通过泪液功能指数试验(TFI)计算。
在暴露于干燥环境之前(防护)和之后(缓解),TSP/HA导致平均泪液渗透压分别为296.0 mOsm/L和292.0 mOsm/L,无显著统计学差异。在防护和缓解模式下TSP/HA的存在均导致泪液分泌增加。与在5%RH下不使用TSP/HA眼药水相比,TSP/HA眼药水对OST没有显著影响。平均症状评分从40%RH时的14显著增加到5%RH时的128(p = 0.003)。与不使用眼药水时相比,在防护(暴露前)(35)(p = 0.003)和缓解(暴露后)(50)(p = 0.005)两种情况下症状均有大幅减轻。
显然,在渗透压和眼部舒适度方面,使用TSP/HA进行防护优于缓解。为了优化TSP/HA的治疗效果,建议指导患者在暴露于干燥大气条件之前使用。小样本量限制了研究结果的推广能力。未来的研究应该用更大的样本评估泪液补充剂以提高统计效力。