Topical Cyclosporine A 0.05% for the Treatment of Dry Eye Disease

Dry eye disease (DED) is a common clinical condition that challenges ophthalmologists. Topical Cyclosporine A is an anti-inflammatory therapy being approved by the Food and Drug Administration (FDA) for the therapy for DED. This study aimed to evaluate the efficacy and pa- tient tolerability of topical Cyclosporine A 0.05% for the treatment of DED. A total of 87 patients diagnosed with DED were included in this study. Dry eye symptoms (foreign body sensation, burn- ing, and pain) were scored. As a baseline measurement, the tear break-up time test (TBUT) and the Schirmer’s test were performed for all the patients. Cyclosporine A 0.05% was given topically twice daily to all the patients for four months. They were followed up every month for a period of four months. The clinical signs (Schirmer’s test, the TBUT), and the symptoms scores, were record- ed for each visit. The mean age of the patients was 57.25±9.70 years (Range 32 - 80 years); 25 males (28.7%) and 62 females (71.3%). Out of them, 23 (26.4%) cases had Sjögren’s syndrome, and 12 (13.7%) cases had previous LASIK (laser in-situ keratomileusis). The symptoms score of the cases improved from (4.95±1.73) pretreatment to (0.40±.70) four months after treatment (P <0.001). The Schirmer’s test results improved from (4.10 ±1.089) pretreatment to (10.80±2.40) four months post-treatment (P <0.0001), and the TBUT test results improved from (5.54±1.77 s) pre- treatment to (12.95±3.12 s) four months post-treatment (P <0.0001). Only seven patients (8%) de- veloped ocular side effects in the form of redness, pain, and systemic side effects in the form of headache. In conclusion, Cyclosporine A 0.05% eye drops is an effective treatment for DED, im- proving both signs and symptoms of DED with few ocular side effects.

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A comparative assessment of dry eye disease among outdoor street sweepers and indoor office cleaners

BMC Ophthalmology ◽

10.1186/s12886-021-02025-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Chigozie I. Echieh ◽

Bassey A. Etim ◽

Chidiebere Peter Echieh ◽

Taiwo Oyeniyi ◽

Jeff Ajewole

Keyword(s):

Dry Eye ◽

Cross Sectional Study ◽

Dry Eye Disease ◽

Eye Disease ◽

Ocular Surface Disease Index ◽

Simultaneous Exposure ◽

Cross Sectional ◽

Systematic Random Sampling ◽

Schirmer’S Test ◽

Multi Stage

Abstract Background Occupational predisposition to dry eye disease is known. Simultaneous exposure to multiple factors may pose more risk. Street sweepers are exposed to sunlight in addition to dust which all sweepers are exposed to. Tropical climate predisposes to significant exposure to sunlight. Combined exposure to dust and sunlight may lead to a synergy of factors. This study aims to assess the prevalence of dry eye disease (DED) amongst Street sweepers and Office cleaners in Calabar metropolis. Methods A cross-sectional study was conducted among street sweepers and office cleaners. A systematic random sampling and multi-stage sampling method were used to select street sweepers (n = 115) and office cleaners (n = 115) respectively for the study. A pretested semi-structured interviewer-administered questionnaire was used to obtain information after which the respondents had an ophthalmic examination. An assessment of DED was done with Ocular Surface Disease Index (OSDI) questionnaire, Schirmer’s test, and tear break up time (TBUT). OSDI scores of 33 and above; Schirmer’s test readings of < 10 mm wetting in 5 min and a TBUT of less than 10s in either eye were considered as positive dry eye disease. Results The majority of respondents were females 215(93.5%) compared to males 15 (6.5%). The overall mean age of respondents was 40.96 ± 9.8 years. The average OSDI score, Schirmer’s test as well as TBUT among participants was 26.4 ± 16.0, 16.44 ± 9.52 mm, and 12.38 ± 4.53 s respectively. The prevalence of DED among Street sweepers was 35.7% compared to 20% among office cleaners using the OSDI questionnaire (p = 0.352). The prevalence of DED among street sweepers was 32.2% compared to 30.4% among Office cleaners using the Schirmer’s test. (p = 0.73) The TBUT reported a prevalence of 38.3% of DED among Street sweepers compared to 32.2% in office cleaners. (p = 0.48) Overall; the prevalence of dry eye disease among Street sweepers and office cleaners using OSDI score, Schirmers test, as well as TBUT were not statistically significant (> 0.05) Street Sweepers had higher odds of developing dry eye disease compared to office cleaners (OR = 2.085; C.I. =1.106–3.929; p = 0.02). Negative correlation coefficient was observed between TBUT and OSDI (rs = − 0.102; p = 0.125). This was not statistically significant. Conclusion Street sweepers had a higher prevalence of dry eye disease compared to office cleaners due to a higher risk of increased exposure to environmental factors such as dust, smoke, and sunlight. This effect is possibly due to a synergy of factors. Studies on dose-response are warranted.

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

European Journal of Ophthalmology ◽

10.5301/ejo.5001002 ◽

2017 ◽

Vol 27 (6) ◽

pp. 678-685 ◽

Cited By ~ 19

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.

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Author's Reply to: “Concerns Over: Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease”

European Journal of Ophthalmology ◽

10.5301/ejo.5001043 ◽

2017 ◽

Vol 27 (6) ◽

pp. e194-e195

Author(s):

Andrea Leonardi ◽

Gysbert Van Setten ◽

Mourad Amrane ◽

Dahlia Ismail ◽

Jean-Sebastien Garrigue ◽

...

Keyword(s):

Dry Eye ◽

Cyclosporine A ◽

Dry Eye Disease ◽

Eye Disease ◽

Efficacy And Safety

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Subgroup analysis of two phase III studies of 0.1% cyclosporine A cationic emulsion (CsA CE) in patients with dry eye disease

Acta Ophthalmologica ◽

10.1111/j.1755-3768.2016.0552 ◽

2016 ◽

Vol 94 ◽

Cited By ~ 1

Author(s):

A. Leonardi ◽

G. Garhöfer ◽

M. Amrane ◽

J.S. Garrigue ◽

D. Ismail ◽

...

Keyword(s):

Dry Eye ◽

Cyclosporine A ◽

Subgroup Analysis ◽

Dry Eye Disease ◽

Phase Iii ◽

Eye Disease ◽

Two Phase ◽

Phase Iii Studies

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A Review of the Mechanism of Action of Cyclosporine A: The Role of Cyclosporine A in Dry Eye Disease and Recent Formulation Developments

Clinical Ophthalmology ◽

10.2147/opth.s279051 ◽

2020 ◽

Vol Volume 14 ◽

pp. 4187-4200

Author(s):

Laura M Periman ◽

Francis S Mah ◽

Paul M Karpecki

Keyword(s):

Dry Eye ◽

Mechanism Of Action ◽

Cyclosporine A ◽

Dry Eye Disease ◽

Eye Disease ◽

Recent Formulation

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Dry Eye Disease among Pregnant Women at a Tertiary Care Hospital in Kathmandu

Nepal Medical College Journal ◽

10.3126/nmcj.v22i3.32640 ◽

2020 ◽

Vol 22 (3) ◽

pp. 146-152

Author(s):

Aparna Rizyal ◽

B Shrestha ◽

A Khadka

Keyword(s):

Pregnant Women ◽

Dry Eye ◽

Tertiary Care ◽

College Teaching ◽

Dry Eye Disease ◽

Eye Disease ◽

Care Hospital ◽

Dry Eyes ◽

Schirmer’S Test ◽

Woman's Body

Pregnancy is characterized by many significant changes in a woman’s body which helps develop the fetus optimally. During pregnancy, there is marked maternal endocrine upregulation, hormonal profile modifications and interactions leading to dry eyes. Pregnancy causes most parts of a woman’s body to change, and the eyes are no exception. Dry eye disease is a common pregnancy problem that usually begins towards the end of the first trimester. Since, there is a dearth of literature on dry eye disease during pregnancy in Nepal, a study was conducted to estimate the prevalence of dry eyes disease among pregnant women and to find its association with socio-demographic characteristics and their gestation period, at Nepal Medical College Teaching Hospital. A total of 84 pregnant women in different trimesters volunteered for this study. The upper and lower limits for estimated mean age were 26.67 years to 25.03 years at 95% confidence level. The prevalence of dry eyes was 89.3% by tear break up time test and 27.4% by Schirmer’s test respectively. The association between gestational age and dry eyes by Schirmer’s test was statistically significant.

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