scholarly journals Efficacy and Safety of VisuEvo® and Cationorm® for the Treatment of Evaporative and Non-Evaporative Dry Eye Disease: A Multicenter, Double-Blind, Cross-Over, Randomized Clinical Trial

2020 ◽  
Vol Volume 14 ◽  
pp. 1651-1663
Author(s):  
Paolo Fogagnolo ◽  
Chiara Quisisana ◽  
Anna Caretti ◽  
Daniele Marchina ◽  
Michele Dei Cas ◽  
...  
2021 ◽  
Author(s):  
Marina Rodríguez Calvo‐de‐Mora ◽  
Cayetano Domínguez‐Ruiz ◽  
Francisco Barrero‐Sojo ◽  
Gustavo Rodríguez‐Moreno ◽  
Cristina Antúnez Rodríguez ◽  
...  

2021 ◽  
Author(s):  
xue zhang ◽  
Bo Zhang ◽  
Siyang Peng ◽  
Guoliang Zhang ◽  
Jumei Ma ◽  
...  

Abstract BackgroundThe global incidence of dry eye disease (DED) is very high. DED seriously affects the quality of life of patients; however, the current curative effect of medicine for moderate to severe DED is poor. This randomized clinical trial was planned to investigate the effect of acupuncture compared with artificial tears on moderate to severe DED.MethodsA randomized clinical trial was performed at 2 hospitals in China. 120 DED patients were randomly equally divided into an acupuncture and an artificial tear group. Either acupuncture or artificial tears was performed for an 8-week period, and a 32-week follow-up was performed. The primary outcome measure was the Schirmer-I test (SIT) value. The secondary outcome measures included the numerical rating scale (NRS) for improvement in ocular symptoms, the ocular surface disease index (OSDI), the tear-film break-up time (TBUT), corneal fluorescein staining (CFS), and acupuncture acceptability. Adverse events also were monitored and documented.ResultsFor the primary outcome, the mean changes in the SIT values were significantly different between the acupuncture (5.75 [2.53‒9.75]) and artificial tear (0.52 [-1.18‒2.46]) groups at week 8 (P = 0.01). The OSDI decreased by -16.14 (-35.40‒16.30) and − 7.65 (-19.25‒15.05) from baseline to week 8 in the acupuncture and artificial tear groups, respectively (P < 0.05). A significant decrease was found in the NRS score for eye dryness, eye pain, and blurred vision in the acupuncture group, as compared to the artificial tear group. However, the change in the average symptom NRS score, TBUT, and CFS did not differ significantly at week 8. Five cases experienced acupuncture-related adverse events.ConclusionsThis randomized clinical trial found that acupuncture at a single acupoint, BL1, significantly promoted tear secretion and improved multiple eye discomfort symptoms. Acupuncture showed greater benefits than artificial tears for moderate to severe DED. However, the study findings warrant verification.Trial registrationRegistration number: ChiCTR1800015831. Name of trial registry: Efficacy and safety of acupuncture in the treatment of moderate to severe dry eye disease: a randomized controlled trial.


2020 ◽  
Vol Volume 14 ◽  
pp. 1665-1673 ◽  
Author(s):  
Gary Jerkins ◽  
Jack V Greiner ◽  
Louis Tong ◽  
Jacqueline Tan ◽  
Joseph Tauber ◽  
...  

2021 ◽  
Vol 8 ◽  
Author(s):  
Tong Lin ◽  
Wushuang Wang ◽  
Yang Lu ◽  
Lan Gong

Background: Punctal/intracanalicular plugs on the market nowadays are all designed before clinical use in treating dry eye disease (DED). To provide an individualized lacrimal drainage system occlusion method and reduce the complications, we developed a “liquid plug” strategy by intracanalicular injection of hydroxybutyl chitosan (HBC) solution, a thermosensitive, phase-changing biomaterial. This study evaluated the efficacy and safety of the HBC plug in treating dry eye disease by comparing it with the VisiPlug absorbable intracanalicular plug.Methods: A monocenter, randomized, controlled clinical trial was performed. Fifty patients with DED were randomized 1:1 to undergo either the HBC injection treatment or the VisiPlug treatment. Ocular Surface Disease Index (OSDI) questionnaire, tear break-up time (TBUT), corneal fluorescence staining (CFS), tear meniscus height (TMH), and phenol red thread test were evaluated at Day 0 (baseline, before treatment) and Weeks 1, 4, and 12.Results: The two groups had a balanced baseline of age, gender, and DED-related characteristics. Both occlusion methods could relieve the symptoms and signs of DED. Significant improvement was found in OSDI, phenol red thread test, and tear meniscus height (P &lt; 0.05 compared to baseline) but not in corneal fluorescence staining and tear break-up time (P &gt; 0.05). There is no statistically significant difference between HBC injection and VisiPlug at Weeks 1 and 4 (P &gt; 0.05). However, at week 12, the HBC injection was not as effective as the VisiPlug in maintaining phenol red thread test (HBC: 5.35 ± 3.22 mm, VisiPlug: 8.59 ± 4.35 mm, P = 0.009) and tear meniscus height (HBC: 206.9 ± 47.95 μm, VisiPlug: 242.59 ± 60.30 μm, P = 0.041). The numbers of ocular adverse events were relatively low in both groups.Conclusions: The HBC injection showed similar efficacy and safety compared to VisiPlug. The intracanalicular injection of HBC solution proves to be a promising, individualizing method to treat DED.Clinical Trial Registration: This study is registered with the Chinese Clinical Trial Registry (https://www.chictr.org.cn/enindex.aspx), Identifier: ChiCTR1800016603.


Author(s):  
Vidya K. Sudarshan ◽  
Joel E. W. Koh ◽  
U. Rajendra Acharya ◽  
Jen Hong Tan ◽  
Muthu Rama Krishnan Mookiah ◽  
...  

2021 ◽  
Vol 37 (1) ◽  
pp. 4-11
Author(s):  
Jeongah Shin ◽  
Chang Rae Rho ◽  
Joon Young Hyon ◽  
Tae-Young Chung ◽  
Kyung Chul Yoon ◽  
...  

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