Core Outcome Sets for Clinical Trials in Dry Eye Disease

2018 ◽  
Vol 136 (10) ◽  
pp. 1180 ◽  
Author(s):  
Michael T. M. Wang ◽  
Jennifer P. Craig
Keyword(s):  
Clinical Trials ◽  
Dry Eye ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Core Outcome ◽  
Core Outcome Sets

scholarly journals Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials

2019 ◽  
Vol 17 (1) ◽  
pp. 142-150 ◽  
Author(s):  
John D. Sheppard ◽  
Gail L. Torkildsen ◽  
Joel A. Geffin ◽  
Jung Dao ◽  
David G. Evans ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Dry Eye ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Tear Production

scholarly journals The Association between Tear Film Thickness as Measured with OCT and Symptoms and Signs of Dry Eye Disease: A Pooled Analysis of 6 Clinical Trials

2020 ◽  
Vol 9 (11) ◽  
pp. 3791
Author(s):  
Gerhard Garhöfer ◽  
Valentin Aranha Dos Santos ◽  
Hannes Stegmann ◽  
Doreen Schmidl ◽  
Narine Adzhemian ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Film Thickness ◽  
Dry Eye ◽  
Tear Film ◽  
Pooled Analysis ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Break Up ◽  
Symptoms And Signs ◽  
Schirmer I Test

Purpose: To determine the association between tear film thickness (TFT) as measured with ultra-high resolution optical coherence tomography (UHR-OCT) and signs and symptoms of dry eye disease (DED). Methods: A total of 450 eyes from 225 patients with DED from six different randomized clinical trials were included in this pooled analysis. In all subjects, TFT was measured with a custom-built UHR-OCT system. Symptoms of DED were quantified using a standardized Ocular Surface Disease Index (OSD)I questionnaire and clinical signs including tear film break up time (TFBUT) and Schirmer I test were assessed. Associations of the average TFT with OSDI, TFBUT, and Schirmer I test were calculated using a linear regression analysis. Results: The average TFT of the included sample (mean age, 45.0 ± 13.3 years; 65% female) was 4.2 ± 0.5 µm and the OSDI 36.2 ± 10.4. A significant negative correlation was found between TFT and OSDI (r = −0.36 to −0.31; p < 0.001). Tear break up time and Schirmer I test were not correlated with OSDI. Significant albeit weak correlations were found between TFT and TFBUT (r = 0.17 to 0.25; p < 0.01) as well as Schirmer I (r = 0.36 to 0.37; p < 0.001). Subgroup analysis revealed that the correlation was stronger in the subjects with abnormal Schirmer I (<15 mm; r = 0.50 to 0.54; p < 0.001). Conclusions: The present study demonstrates an objective measurement of TFT using a novel OCT approach for DED that correlates with symptoms and signs of DED. Our data are consistent with the idea that TFT represents the aqueous-deficient component of DED.

scholarly journals Safety and Efficacy Clinical Trials for SYL1001, a Novel Short Interfering RNA for the Treatment of Dry Eye Disease

2016 ◽  
Vol 57 (14) ◽  
pp. 6447 ◽  
Author(s):  
José Manuel Benitez-Del-Castillo ◽  
Javier Moreno-Montañés ◽  
Ignacio Jiménez-Alfaro ◽  
Francisco José Muñoz-Negrete ◽  
Krista Turman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Dry Eye ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Short Interfering Rna ◽  
Safety And Efficacy ◽  
Interfering Rna

scholarly journals Methods of drug therapy for severe dry eye disease

2021 ◽  
Vol 18 (1) ◽  
pp. 109-116
Author(s):  
G. R. Semak
Keyword(s):  
Clinical Trials ◽  
Drug Therapy ◽  
Dry Eye ◽  
Ocular Surface ◽  
High Efficiency ◽  
Platelet Rich Plasma ◽  
Sodium Hyaluronate ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Pubmed Database

Treatment of chronic dystrophic diseases of the ocular surface always requires concomitant correction of severe dry eye disease (DED). The purpose of this publication was to analyze the literature data illustrating the current trends in the development of drug therapy for severe dry eye disease of non-Shegren’s etiology.The search for thematic publications was carried out in the PubMed database. The query “(dry-eye-disease AND treatment) NOT Sjögren” (filter: clinical trials, randomized controlled clinical trials, meta-analyzes) found 56 results since 2019.The review included 11 publications describing the results of clinical studies of the effectiveness of drug methods in the treatment of severe DED.In the treatment of severe DED, the prevailing direction of research is the relief of inflammation in the ocular surface tissues. Among the non-steroidal immunomodulatory drugs, the majority of studies were dedicated to cyclosporine, including its nanoemulsion form, diquafosol and bevacizumab. Their effectiveness and safety have been proven. In the Republic of Belarus, there is no unified approach to the management of patients with severe and comorbid DED. The main focus is on the activation of regenerative processes. Platelet rich plasma and subconjunctival administration of low molecular weight sodium hyaluronate demonstrated high efficiency.

scholarly journals Effects of Polyunsaturated Fatty Acids on Nonspecific Typical Dry Eye Disease: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Nutrients ◽  
2019 ◽  
Vol 11 (5) ◽  
pp. 942 ◽  
Author(s):  
Sheng-Chu Chi ◽  
Hsin-I Tuan ◽  
Yi-No Kang
Keyword(s):  
Fatty Acids ◽  
Clinical Trials ◽  
Polyunsaturated Fatty Acids ◽  
Dry Eye ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Dry Eye Disease ◽  
Cochrane Library ◽  
Eye Disease ◽  
Short Term Treatment

To investigate the effects of polyunsaturated fatty acids (PUFAs) in patients with dry eye disease (DED), a multifactorial inflammatory disorder, we searched Cochrane Library, EMBASE, PubMed, and Web of Science for randomized clinical trials (RCTs) investigating the effect of PUFAs in patients with DED before March 2019. Two reviewers independently abstracted data of tear breakup time (TBUT), Schirmer’s test, osmolarity, and ocular surface disease index (OSDI). We conducted pairwise meta-analysis using means and standard deviations (SDs) in a random-effects model for continuous outcomes. Thirteen eligible RCTs with 1782 patients with nonspecific typical DED were included. Patients who received PUFA treatment without other eye medications exhibited greater improvements in TBUT (MD = 1.80; p = 0.001), Schirmer test scores (MD = 0.50; p < 0.001), osmolarity (MD = −15.95; p < 0.001), and OSDI scores (MD = −10.19; p < 0.001) than those who received placebo treatment. However, the effects of PUFAs on TBUT (p < 0.001) and OSDI scores (p = 0.03) weakened with treatment duration. PUFAs are effective in treating nonspecific typical DED, particularly as a short-term treatment, with relatively few adverse events. Therefore, in real-world clinical practice, PUFA supplements are worth being suggested to patients with nonspecific typical DED who are not concurrently using other topical or systematic eye medications.

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