scholarly journals A Comparison of Symptoms and Signs in Patients with Inflammatory Dry Eye Disease using two Commercially Available Treatment Formulations of Cyclosporine A

Author(s):  
Jonatan Olafsson ◽  
Snorri Olafsson ◽  
Hugo Lewi Hammer ◽  
Behzod Tashbayev ◽  
Øygunn A. Utheim ◽  
...  

Abstract Purpose: Dry eye (DED) is a multifactorial disease of the ocular surface in which ocular surface inflammation and damage play etiological roles. In the present study, we compared symptoms and signs in patients with DED treated with 0.1% Cyclosporine A (CsA) cationic emulsion (Ikervis, Santen) and 0.05% CsA anionic emulsion (Restasis, Allergan).Methods: Single-center, retrospective, 202 consecutive DED patients were treated with 0.1% CsA cationic emulsion (Ikervis, n=101) or 0.05% CsA anionic emulsion (Restasis, n=101) over six months. Ophthalmological work-up included Ocular Surface Disease Index (OSDI) questionnaire, fluorescein break-up time (FBUT), fluorescein ocular surface staining (OSS), Schirmer’s test, meibum expressibility (ME), and meibum quality (MQ). Results: In both treatment groups, subgroup analysis revealed a significant improvement of OSDI only in patients with severe symptoms at baseline (OSDI 33-100). Ikervis-treated patients with OSDI <23 at baseline had a significant increase in symptoms. OSS and FBUT improved significantly in most subgroups irrespective of Ikervis or Restasis being used. Regression analysis revealed a significant superiority to Restasis with regard to FBUT improvement and superiority to Ikervis in regards ME improvement. Conclusions: We conclude that there is seemingly no substantial difference in efficacy between the two drugs. The strength of Restasis is increased efficacy at improving FBUT and of Ikervis improving ME.

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Jang Hoon Lee ◽  
In Seok Song ◽  
Kyoung Lae Kim ◽  
Sam Young Yoon

Purpose.To evaluate the effectiveness and optical quality of 3.0% topical diquafosol versus 0.05% cyclosporine A in dry eye patients following cataract surgery.Methods.In total, 40 eyes of 40 patients newly diagnosed with dry eye syndrome 1 week after cataract surgery were randomized to receive either 3.0% diquafosol ophthalmic solution six times daily or 0.05% cyclosporine A twice daily for 3 months. Outcome measures were tear film break-up time (TBUT), results on Schirmer 1 test, ocular surface staining score, the ocular surface disease index (OSDI) score, and higher-order aberrations (HOAs). Measurements were taken at baseline and at 1, 2, and 3 months.Results.In the diquafosol group, TBUT showed higher outcomes than the cyclosporine A group at 1 and 3 months. Both groups showed increased scores on Schirmer 1 test. The ocular surface staining score decreased in all periods in both groups. Vertical coma and total HOAs decreased more in the cyclosporine A group than in the diquafosol group at 3 months.Conclusion.Both 3.0% diquafosol and 0.05% cyclosporine A were effective in treating dry eye after cataract surgery. Diquafosol was more effective in increasing the tear secretion, but cyclosporine A was more effective in improving optical aberrations.


2017 ◽  
Vol 27 (6) ◽  
pp. 678-685 ◽  
Author(s):  
Christophe Baudouin ◽  
Maite Sainz de la Maza ◽  
Mourad Amrane ◽  
Jean-Sébastien Garrigue ◽  
Dahlia Ismail ◽  
...  

Purpose The SANSIKA study evaluated the efficacy/safety of 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) for treating dry eye disease (DED) with severe keratitis. The double-masked phase demonstrated that CsA CE was effective in reducing corneal damage and ocular surface inflammation, and was well-tolerated over 6 months. Here we report efficacy and safety findings of SANSIKA's open-label extension (OLE). Methods In this multicenter, double-masked, phase III study, patients with severe DED (corneal fluorescein staining [CFS] grade 4, modified Oxford scale) were randomized to once-daily CsA CE (Ikervis®) or its vehicle for 6 months, followed by 6-month open-label, once-daily CsA CE (CsA CE/CsA CE and vehicle/CsA CE groups). Results A total of 177 patients completed the OLE. Efficacy results reiterated the double-masked phase: CsA CE reduced CFS score and human leukocyte antigen-antigen D related expression, improved corneal clearing, and produced continuous improvements in global symptom scores (ocular surface disease index [OSDI], visual analogue scale). The CFS-OSDI response rates (≥2 CFS points, ≥30% OSDI improvement vs baseline) at 12 vs 6 months were 39.1% vs 28.6%, respectively, for CsA CE/CsA CE and 38.0% vs 23.1% for vehicle/CsA CE. Cyclosporine A CE's safety profile was similar to the initial 6 months. The most common treatment-related treatment-emergent adverse event was instillation site pain (7.8%, CsA CE/CsA CE group; 19.0%, vehicle/CsA CE group). No unexpected safety signals were observed; systemic CsA levels were undetectable/negligible in all patients except 2 previously treated with systemic CsA. Conclusions In this 12-month study, once-daily CsA CE was well-tolerated and showed reductions in ocular surface inflammation and improvements in signs/symptoms in DED patients with severe keratitis.


2019 ◽  
Vol 104 (2) ◽  
pp. 260-264 ◽  
Author(s):  
Monika Farhangi ◽  
Ryan J Diel ◽  
Dawn C Buse ◽  
Amy Michelle Huang ◽  
Roy C Levitt ◽  
...  

BackgroundMany individuals with migraine report symptoms of dry eye (DE). However, it is not known whether DE profiles are similar between individuals with and without migraine. To bridge this gap, we evaluated symptoms and signs of DE, including symptoms suggestive of nerve dysfunction, in a large group of individuals with DE symptoms, and compared profiles between individuals with migraine and those without migraine or headache.MethodsProspective cross-sectional study of individuals with DE symptoms seen at the Miami VA.ResultsOf 250 individuals, 31 met International Classification of Headache Disorders criteria for migraine based on a validated screen. Individuals with migraine were significantly younger (57 vs 62 years) and more likely to be female (26% vs 6%) than controls. Individuals with migraine had more severe DE symptoms and ocular pain compared with controls (mean Ocular Surface Disease Index 53.93 ± 21.76 vs 36.30 ± 22.90, p=0.0001; mean Neuropathic Pain Symptom Inventory modified for the Eye 39.39 ± 23.33 vs 21.86 ± 20.17, p=0.0001). The difference in symptom profile occurred despite similar ocular surface parameters between the groups.ConclusionsIndividuals with migraine had a different DE symptom yet a similar DE sign profile when compared with controls without migraine. This suggests that DE symptoms in individuals with migraine may be driven by nerve dysfunction as opposed to ocular surface abnormalities.


2017 ◽  
Vol 27 (5) ◽  
pp. 520-530 ◽  
Author(s):  
Christophe Baudouin ◽  
Francisco C. Figueiredo ◽  
Elisabeth M. Messmer ◽  
Dahlia Ismail ◽  
Mourad Amrane ◽  
...  

Purpose The SICCANOVE study aimed to compare the efficacy and safety of 0.1% cyclosporine A cationic emulsion (CsA CE) versus vehicle in patients with moderate to severe dry eye disease (DED). Methods In this multicenter, double-masked, parallel-group, controlled study, patients were randomized (1:1) to receive CsA CE (Ikervis®) or vehicle for 6 months. The co-primary efficacy endpoints at month 6 were mean change from baseline in corneal fluorescein staining (CFS; modified Oxford scale) and in global ocular discomfort (visual analogue scale [VAS]). Results The mean change in CFS from baseline to month 6 (CsA CE: n = 241; vehicle: n = 248) was significantly greater with CsA CE than with vehicle (-1.05 ± 0.98 and -0.82 ± 0.94, respectively; p = 0.009). Ocular discomfort improved similarly in both groups; however, the percentage of patients with ≥25% improvement in VAS was significantly higher with CsA CE (50.2%) than with vehicle (41.9%; p = 0.048). In a post hoc analysis of patients with severe ocular surface damage (CFS score 4) at baseline (CsA CE: n = 43; vehicle: n = 42), the percentage of patients with improvements of ≥2 grades in CFS score and ≥30% in Ocular Surface Disease Index score was significantly greater with CsA CE (p = 0.003). Treatment compliance and ocular tolerability were satisfactory and as expected for CsA use. Conclusion Cyclosporine A CE was well-tolerated and effectively improved signs and symptoms in patients with moderate to severe DED over 6 months, especially in patients with severe disease, who are at risk of irreversible corneal damage.


Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1526
Author(s):  
Jin Ju Choi ◽  
Jin Sun Hwang ◽  
Young Joo Shin

Keratoconjunctivitis sicca (KCS) or dry eye is a disease characterized by ocular surface symptoms. This study aimed to investigate the effectiveness of oral choline alfoscerate (CA) administration as a treatment for KCS. The medical records of dry eye patients who were refractory to topical eyedrops and then took oral CA were reviewed. Results of tear break-up time (TBUT), fluorescein ocular surface staining score (FSS), and tear secretion by the Schirmer test (STT) were analyzed. The results of the ocular surface disease index (OSDI), visual analog pain score (VAS), reporting of the severity and frequency of symptoms, and the modified Standardized Patient Evaluation of Eye Dryness (SPEED) questionnaire were also analyzed. The records of 47 patients were analyzed for this study. The mean age was 62.8 ± 9.3 years, and the patients included 9 males and 38 females. TBUT, OSDI, and VAS significantly improved after CA administration compared to before (p < 0.05, paired t-test). After CA administration, symptom frequency and impact on life improved (p < 0.05, paired t-test). No significant change in photophobia or FSS was identified. In conclusion, oral CA administration was effective in improving tear stability and alleviating symptoms of KCS.


2020 ◽  
Vol 36 (4) ◽  
Author(s):  
Muhammad Saeed Iqbal ◽  
Kanwal Latif

Purpose:  To determine the role of 0.05% topical cyclosporine A (CsA) in treatment of symptomatic dry eye after LASIK (Laser-Assisted in Situ Keratomileusis). Study Design:  Interventional Case Series. Place and Duration of Study:  Ophthalmology Department, Sir Syed Hospital, Karachi, from July 2018 to Dec. 2019. Methods:  Seventy-five patients who underwent LASIK for myopic refractive error and presented with symptomatic dry eye and showed no response to artificial tears therapy after 1 month of LASIK were selected. The patient had ablation zone diameter of 6mm and flap diameter was 8.5mm to 9mm. Cyclisporine A 0.05% ophthalmic preparation was added to treatment regimen and response was observed at 1, 3 and 6 months. OSDI (Ocular Surface Disease Index) scores, Tear film break up time (TBUT), Schirmer's test (ST) values and Best Corrected Visual Acuity (BCVA) were recorded to analyze the treatment response at each visit. The statistical interpretation was done by using SPSS version 21. To interpret the correlation between pre-treatment and 6 month post treatment, Paired sample T test was applied with 95% Confidence Interval; CI and p-value of ≤ 0.05. Results:  The mean post-LASIK OSDI score of enrolled patients was 54.25 ± 10.81. After 6 months of treatment mean OSDI score was improved to 21.05 ± 5.13 (p < 0.001). Post-LASIK mean ST value was 5.2 ± 1.2 mm and mean TBUT value was 5.6 ± 1.3 seconds, which changed to 9.8 ± 1.0 mm and 8.9 ± 1.1 seconds respectively. BCVA improved from Log MAR 0.14 ± 0.09 to 0.01 ± 0.03 (p < 0.001). Conclusion:  Topical CsA 0.05% was effective in alleviating the symptoms of post-LASIK dry eye. Key Words:  LASIK, Dry eye, Ocular Surface Disease Index Score, Cyclosporine A.


Author(s):  
Yunjin Lee ◽  
Joon Young Hyon ◽  
Hyun Sun Jeon

Abstract Purpose To investigate the characteristics of eyes with dry eye disease (DED) whose lipid layer thickness (LLT) measured 100 nm on a LipiView II interferometer and compare the DED parameters of them to those with LLT below 100 nm. Methods A total of 201 eyes of 102 enrolled DED patients (mean age 56.4 ± 11.8 years) were classified into 3 groups according to their average LLT; < 60 nm as thin-LLT (n = 49), 60–99 nm as normal-LLT (n = 77), and 100 nm as thick-LLT (n = 75). LLT, meiboscore, Schirmer I test, tear film break-up time (TBUT), ocular surface staining (OSS), and ocular surface disease index (OSDI) were assessed. Results The OSS and TBUT were significantly worse in the thick-LLT group than in the normal-LLT group (p = 0.020, and p = 0.028, respectively). The OSDI was significantly higher in the thick-LLT group than in the thin-LLT group (p = 0.006). However, the meiboscore was not different among the three groups (p = 0.33). Age, OSS, and OSDI showed a positive correlation with LLT (r = 0.16, p = 0.023; r = 0.213, p = 0.003; and r = 0.338, p = 0.001, respectively). In sensitivity analyses, eyes with corneal erosions had a significantly higher average LLT (p = 0.015), higher OSDI (p = 0.009), shorter TBUT (p < 0.001), and shorter Schirmer I value (p = 0.024) than those with clear corneas. Conclusion The average LLT of eyes with corneal erosions was thicker than those without erosions, suggesting that the LLT of 100 nm in the eyes with corneal erosions should not be regarded as a stable physiologic condition. Cautious interpretation of LLT along with other dry eye parameters is required.


2017 ◽  
Vol 102 (5) ◽  
pp. 674-679 ◽  
Author(s):  
Erin S Ong ◽  
Elizabeth R Felix ◽  
Roy C Levitt ◽  
William J Feuer ◽  
Constantine D Sarantopoulos ◽  
...  

Background/aimsThe frequent lack of association between dry eye (DE) symptoms and signs leads to challenges in diagnosing and assessing the disease.MethodsParticipants underwent ocular surface examinations to evaluate signs of disease and completed questionnaires to assess ocular symptoms, psychological status and medication use. To assess nociceptive system integrity, quantitative sensory testing (QST), including vibratory and thermal threshold measures and temporal summation of pain were obtained at the forearm and forehead. Correlations between DE discordance score (degree of discrepancy between symptom severity and DE signs) and patient characteristics were determined. Higher discordance scores indicated more symptoms than signs.Results326 patients participated (mean age: 62 years; SD: 10 years; 92% men). Age was negatively correlated with DE discordance score (Pearson r=−0.30, p<0.0005), while mental health indices were positively correlated. Chronic pain elsewhere in the body (ie, non-ocular pain conditions) and intensity ratings of prolonged aftersensations of pain evoked by noxious hot and cold stimuli were also significantly correlated with DE discordance score. Multiple linear regression demonstrated that post-traumatic stress disorder and non-ocular pain intensity were important predictors of DE discordance score, Dry Eye Questionnaire-5 and Ocular Surface Disease Index and that DE discordance was also sensitive to QST as well.ConclusionsThe present study provides evidence that the degree of discordance between DE symptom report and measurable signs of ocular surface disease is associated with comorbidities related to clinical pain and to hyperalgesia as demonstrated with QST. Understanding the epidemiology of DE discordance can aid in interpreting the DE exam and individualising treatment.


2020 ◽  
Author(s):  
Haiting Chen ◽  
Xueyan Feng ◽  
Guangzeng Niu ◽  
Yuxiang Fan

<b><i>Objectives:</i></b> To evaluate dry eye (DE) and associated meibomian gland dysfunction parameters after Implantable Collamer Lens (ICL) surgery. <b><i>Methods:</i></b> This is a prospective observational case series. Patients who underwent ICL implantation without previous ocular diseases or ophthalmic treatments were enrolled. Their Ocular Surface Disease Index (OSDI), noninvasive breakup time (NIBUT), meibography, slit-lamp examination of the lid margin, corneal fluorescein staining (CFS), and Schirmer test I were examined preoperatively and at 1 and 3 months postoperatively. <b><i>Results:</i></b> A total of 117 eyes of 60 patients were enrolled, and 107 eyes completed 3-month follow-up period. OSDI, lid marginal abnormality, and meibomian gland (MG) secretion, and meibum quality score were significantly higher at 1 month postoperatively and recovered partially at 3 months after surgeries, while NIBUT was significantly decreased all the time. Patients with previous DE symptoms (OSDI score ≥12) showed not only lower Schirmer and TBUT values but also higher CFS, lid margin score, MG loss, MG secretion, and meibum quality scores compared with those in the control group after operations. Low Schirmer, NIBUT values, and high meibum quality score were determined as risk factors for DE symptoms after ICL surgery. <b><i>Conclusions:</i></b> ICL implantation has a bad influence on the ocular surface and MG functions. The influence may be more obvious in patients with existing DE.


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