scholarly journals A Randomized Study of the Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in Treatment of Moderate to Severe Dry Eye

2017 ◽  
Vol 27 (5) ◽  
pp. 520-530 ◽  
Author(s):  
Christophe Baudouin ◽  
Francisco C. Figueiredo ◽  
Elisabeth M. Messmer ◽  
Dahlia Ismail ◽  
Mourad Amrane ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Ocular Surface ◽  
Severe Disease ◽  
Randomized Study ◽  
Treatment Compliance ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Ocular Surface Disease Index ◽  
Ocular Discomfort

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.

scholarly journals One-Year Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease

2017 ◽  
Vol 27 (6) ◽  
pp. 678-685 ◽  
Author(s):  
Christophe Baudouin ◽  
Maite Sainz de la Maza ◽  
Mourad Amrane ◽  
Jean-Sébastien Garrigue ◽  
Dahlia Ismail ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Surface Inflammation ◽  
Ocular Surface Inflammation

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.

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

2021 ◽  
Author(s):  
Jonatan Olafsson ◽  
Snorri Olafsson ◽  
Hugo Lewi Hammer ◽  
Behzod Tashbayev ◽  
Øygunn A. Utheim ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Ocular Surface ◽  
Ocular Surface Disease Index ◽  
Treatment Groups ◽  
Surface Staining ◽  
Work Up ◽  
Symptoms And Signs ◽  
Significant Superiority ◽  
Ocular Surface Inflammation

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.

scholarly journals Effect of a Novel Multi-Ingredient Formulation on Management of Dry Eye Discomfort in a Randomized, Double-Blind, Placebo-Controlled Human Clinical Study

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 42-42
Author(s):  
Muralidhara Padigaru ◽  
Abhijeet Morde ◽  
Pranav Radkar ◽  
Prabhu Shankar Lakshmanan ◽  
Abhijeet Morde
Keyword(s):  
Dry Eye ◽  
Vitamin D3 ◽  
Ocular Surface ◽  
Test Group ◽  
Surface Damage ◽  
Controlled Study ◽  
Ocular Surface Disease Index ◽  
Double Blind ◽  
Health Technologies ◽  
Artificial Tear

Abstract Objectives Dry eye is a chronic condition associated with insufficient tear production and faster tear evaporation and commonly accompanied by inflammation that may lead to ocular surface damage. We have developed a multi-ingredient formulation containing lutein, zeaxanthin, curcumin, and vitamin D3 to address conditions associated with dry eye. The objective of this study was to evaluate the efficacy and safety of our formulation in subjects with mild to moderate dry eye symptoms. Methods This was a randomized, double-blind, parallel, placebo-controlled study. Sixty subjects with mild to moderate DES were randomly assigned in a 1 : 1 ratio to the test or placebo groups. Subjects consumed one capsule of the test or placebo product every morning through the study duration of 56 days. The test product comprised 20 mg lutein, 4 mg zeaxanthin, 200 mg curcuminoids, and 600 IU vitamin D3 in form of a capsule. The placebo product contained soybean oil.  Changes in tear volume by Schirmer's test and severity of dry eye discomfort measured by Ocular Surface Disease Index (OSDI) score, changes in Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film break up time (TBUT), corneal & conjunctival staining, tear osmolarity, Matrix Metalloproteinases (MMP)-9 levels in tear fluid, and artificial tear usage were evaluated. Results Thirty subjects in Test and 29 in Placebo group completed study. We observed statistically significant (P &lt; 0.05) improvements in tear volume, TBUT, and a reduction in dry eye discomfort as measured by OSDI and SPEED scores from baseline to day 56 in the Test group. Mean corneal & conjunctival staining scores, tear osmolarity and tear MMP-9 levels also showed significant improvements (P &lt; 0.05) when compared to Placebo on day 56. Artificial tear usage & frequency of usage were significantly reduced (P &lt; 0.05) in test group as compared to Placebo. Products were well tolerated without any adverse events. Conclusions Our multi-ingredient formulation demonstrated significant improvement in dry eye conditions including eye hydration and moisture, tear stability and quality, and overall improvements in eye comfort. Funding Sources OmniActive Health Technologies

scholarly journals Topical Cyclosporine in Treatment of Post-LASIK Symptomatic Dry Eye

2020 ◽  
Vol 36 (4) ◽  
Author(s):  
Muhammad Saeed Iqbal ◽  
Kanwal Latif
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Ocular Surface ◽  
Case Series ◽  
Tear Film ◽  
Disease Index ◽  
Ocular Surface Disease ◽  
P Value ◽  
Statistical Interpretation ◽  
Ocular Surface Disease Index

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.

scholarly journals Effectiveness and Optical Quality of Topical 3.0% Diquafosol versus 0.05% Cyclosporine A in Dry Eye Patients following Cataract Surgery

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Jang Hoon Lee ◽  
In Seok Song ◽  
Kyoung Lae Kim ◽  
Sam Young Yoon
Keyword(s):  
Cataract Surgery ◽  
Dry Eye ◽  
Cyclosporine A ◽  
Ocular Surface ◽  
Ophthalmic Solution ◽  
Optical Quality ◽  
Ocular Surface Disease Index ◽  
Staining Score ◽  
Surface Staining

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.

scholarly journals Evaluation of Dry Eye after Implantable Collamer Lens Surgery

2020 ◽  
Author(s):  
Haiting Chen ◽  
Xueyan Feng ◽  
Guangzeng Niu ◽  
Yuxiang Fan
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Case Series ◽  
Meibomian Gland ◽  
Quality Score ◽  
Control Group ◽  
Ocular Surface Disease Index ◽  
Implantable Collamer Lens ◽  
Lens Surgery ◽  
Breakup Time

<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.

scholarly journals Dry eye disease among Glaucoma patients on topical hypotensive medications, in a tertiary hospital, Ethiopia

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Miraf Sahlu ◽  
Abeba T. Giorgis
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Signs And Symptoms ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Eye Drops ◽  
Schirmer Test ◽  
Ocular Surface Disease Index ◽  
Cross Sectional ◽  
Corneal Staining

Abstract Background Dry eye disease is a multifactorial disease; causing various ocular symptoms with potential damage to the ocular surface. Applying hypotensive eye drops are presumed to initiate or exacerbate existing dry eye disease. The purpose of this study was to determine the frequency of signs and symptoms and severity of dry eye disease among glaucoma patients on topical hypotensive medications and controls. Methods A cross-sectional comparative study, involving 320 glaucoma patients and controls. Ocular Surface Disease Index (OSDI) symptoms score and Schirmer, tear breakup time and corneal staining tests were used to assess dry eye disease. Data was analyzed using SPSS version 24 software; p-value less than 0.05 was considered as statistically significant. Results Among the 160 study glaucoma patients, the mean duration of topical hypotensive medication use was 5.2 ± 5.21 years (range, 4 months - 32 years). Mild to severe level of OSDI score was found in 122 (76%) glaucoma patients and in 137 (86%) controls (p = 0.033). Mild to sever abnormal clinical tests in the glaucoma patients and control, respectively, were 106 (66%) vs 80 (50%) corneal staining (p = 0.045), 79 (49%) vs 72 (45%) TBUT (p = 0.021), and 91 (57%) vs 83 (52%) Schirmer test (p = 0.242). Test results at the level of sever: 2 (1%) vs 0 (0%) corneal staining, 50 (31%) vs 39 (24%) TBUT and 65 (41%) vs 60 (38%) Schirmer test in the glaucoma patents and controls, respectively. Corneal staining and TBUT had correlation with the number of drugs (p = 0.004 and 0.031, respectively), and more relationship of the two tests with total number of drops applied per day (p = 0.01 and p <  0.001, respectively). Patients on pilocarpine and timolol had more corneal staining and lower TBUT [(p = 0.011 and p <  0.001) and (p = 0.04 and 0.012), respectively]. Conclusions The study has identified glaucoma patients to be more affected by dry eye disease than non-glaucoma patients, and presence of significantly lower TBUT and higher corneal staining in the glaucoma patients on multidrops and multidose per day. We recommend consideration of evaluation and management of DED for glaucoma patients on multidrops and multidose hypotensive medications.

scholarly journals Reliability and validity of the Japanese version of the Ocular Surface Disease Index for dry eye disease

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e033940 ◽  
Author(s):  
Akie Midorikawa-Inomata ◽  
Takenori Inomata ◽  
Shuko Nojiri ◽  
Masahiro Nakamura ◽  
Masao Iwagami ◽  
...  
Keyword(s):  
Internal Consistency ◽  
Dry Eye ◽  
Ocular Surface ◽  
Discriminant Validity ◽  
Reliability And Validity ◽  
Japanese Version ◽  
Disease Index ◽  
Eye Disease ◽  
Ocular Surface Disease Index ◽  
Test Retest Reliability

ObjectivesThe Ocular Surface Disease Index (OSDI) questionnaire is widely used to evaluate subjective symptoms of dry eye disease (DED) as a primary diagnostic criterion. This study aimed to develop a Japanese version of the OSDI (J-OSDI) and assess its reliability and validity.Design and settingHospital-based cross-sectional observational study.ParticipantsA total of 209 patients recruited from the Department of Ophthalmology at Juntendo University Hospital.MethodsWe translated and culturally adapted the OSDI into Japanese. The J-OSDI was then assessed for internal consistency, reliability and validity. We also evaluated the optimal cut-off value to suspect DED using an area under the receiver operating characteristic curve (AUC) analysis.Primary outcome measuresInternal consistency, test–retest reliability and discriminant validity of the J-OSDI as well as the optimal cut-off value to suspect DED.ResultsOf the participants, 152 had DED and 57 did not. The J-OSDI total score showed good internal consistency (Cronbach's alpha=0.884), test–retest reliability (interclass correlation coefficient=0.910) and discriminant validity by known-group comparisons (non-DED, 19.4±16.0; DED, 37.7±22.2; p<0.001). Factor validity was used to confirm three subscales within the J-OSDI according to the original version of the questionnaire. Concurrent validity was assessed by Pearson correlation analysis, and the J-OSDI total score showed a strong positive correlation with the Dry Eye-Related Quality-of-Life Score (γ=0.829). The optimal cut-off value of the J-OSDI total score was 36.3 (AUC=0.744).ConclusionsThe J-OSDI was developed and validated in terms of reliability and validity as an effective tool for DED assessment and monitoring in the Japanese population.

Dry Eye Syndrome-Related Quality of Life in Glaucoma Patients

2009 ◽  
Vol 19 (4) ◽  
pp. 572-579 ◽  
Author(s):  
Gemma Caterina Maria Rossi ◽  
Carmine Tinelli ◽  
Gian Maria Pasinetti ◽  
Giovanni Milano ◽  
Paolo Emilio Bianchi
Keyword(s):  
Quality Of Life ◽  
Dry Eye ◽  
Ocular Surface ◽  
Cross Sectional Study ◽  
Dry Eye Syndrome ◽  
Control Group ◽  
Ocular Surface Disease Index ◽  
Symptom Scale ◽  
Cross Sectional

Purpose To verify the presence of dry eye syndrome (DES) in treated patients with glaucoma and to analyze DES's impact on the patients' quality of life (QOL) versus the control group. Methods In this observational cross-sectional study, 61 patients were enrolled at a clinical practice. Patients were divided into three groups by number of glaucoma drops instilled per day (G1=1 drop/day, G2=2 drops/day, G3=3 drops/day). A control group of 20 subjects was also selected (G0). All subjects were submitted to a complete ocular examination (including tear function and ocular surface status) and completed the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ), Glaucoma Symptom Scale (GSS) questionnaire, and Ocular Surface Disease Index (OSDI). DES was defined as presence of punctate keratitis and decreased break-up time. Statistical analysis was performed applying the Kruskal-Wallis analysis of variance and Mann-Whitney U tests (to compare median values between groups) as well as the χ2 and Fisher test (to verify significant differences). Results A total of 40% of G3 and 39% of G2 patients presented DES versus 11% of G1 and 5% of G0 (p=0.01). QOL was significantly influenced and altered (NEI-VFQ 25 total mean and GSS total mean and symptoms average: p=0.0085, p=0.006, and p=0.03, respectively). OSDI pointed out differences by group: 26% of G2 and 15% of G3 presented moderate OSDI and 15% of G3 and 8.7% of G2 severe OSDI (p>0.05). Conclusions Patients with topically treated glaucoma present DES more often than a similar control group (p=0.01). The presence of DES negatively influences the patient's QOL. The patients with glaucoma's ocular surface status should be evaluated regularly to ensure the timely detection and treatment of pathologic signs on the ocular surface.

The Effect of Low-Dose Aspirin on Dry Eye Parameters and Ocular Surface Disease Index Questionnaire

2018 ◽  
Vol 34 (3) ◽  
pp. 256-259 ◽  
Author(s):  
Alper Yazıcı ◽  
Esin Sarı ◽  
Erkan Ayhan ◽  
Gözde Şahin ◽  
Nesime Setge Tıskaoğlu ◽  
...  
Keyword(s):  
Dry Eye ◽  
Ocular Surface ◽  
Low Dose ◽  
Disease Index ◽  
Ocular Surface Disease ◽  
Ocular Surface Disease Index ◽  
Dose Aspirin ◽  
Low Dose Aspirin
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