Journals / Acıbadem Üniversitesi Sağlık Bilimleri Dergisi / 2022 / Cilt: 13 - Sayı: 2

Generic Cyclosporine in the Treatment of Dry Eye Disease

Kuru Göz Hastalığının Tedavisinde Jenerik Siklosporin

Pages
241–246
Publication Date
2022-10-11
DOI
—
🏛️Bibliographic metadata and full text access for this article are provided via DergiPark.
DergiPark Record ↗
✨

AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

Results: There was a statistically significant improvement from baseline in corneal and conjunctival staining (decrease in mean Oxford score), TBUT, Schirmer-2 values, OSDI score, patient’s subjective rating score for ocular discomfort, and mean physician’s subjective assessment of global response to treatment at all follow-up visits (p

📌 3 Key Takeaways

🎯
Objective & Hypothesis:Objectives: To investigate the efficacy and safety of a generic Cyclosporine 0.05% ophthalmic emulsion in chronic dry eye disease.
📊
Key Findings & Data:Patients were examined at baseline, at month -1,-3 and 6 of the study.
💡
Conclusion & Impact:Results: There was a statistically significant improvement from baseline in corneal and conjunctival staining (decrease in mean Oxford score), TBUT, Schirmer-2 values, OSDI score, patient’s subjective rating score for ocular discomfort, and mean physician’s subjective assessment of global response to treatment at all follow-up visits (p
🔬Design:Research Article
📍Scope:Comprehensive Sample
⚙️Variables:Domain Parameters

Abstract

Objectives: To investigate the efficacy and safety of a generic Cyclosporine 0.05% ophthalmic emulsion in chronic dry eye disease. Materails and Methods: Thirty patients with dry eye disease were included in this observational, prospective study. Patients were examined at baseline, at month -1,-3 and 6 of the study. The following were evaluated at each visit: CDVA (corrected distance visual acuity), corneal and conjunctival staining (Oxford) score, TBUT (tear break-up time), Schirmer-2 score, OSDI (Ocular Surface Disease Index) score, patient’s subjective rating scale of ocular discomfort, daily use of concomittant artificial tears, the researcher’s assessment of the global treatment response, and IOP (intraocular pressure). In addition, drug-related side effects were evaluated individually in each examination. When initiating dry eye treatment, cyclosporine was combined with topical loteprednol etabonate 0.5%. Results: There was a statistically significant improvement from baseline in corneal and conjunctival staining (decrease in mean Oxford score), TBUT, Schirmer-2 values, OSDI score, patient’s subjective rating score for ocular discomfort, and mean physician’s subjective assessment of global response to treatment at all follow-up visits (p

Özet

Amaç: Jenerik %0.05 siklosporin oftalmik emülsiyonunun kronik kuru göz hastalığındaki etkinliğini ve güvenliğini araştırmak. Gereç ve Yöntem: Kuru göz hastalığı olan 30 hasta, bu gözlemsel prospektif çalışmaya dahil edildi. Hastalar başlangıçta, çalışmanın 1., 3. ve 6. ayında değerlendirildi. Çalışmada değerlendirilen parametreler şunlardı: DUGK (düzeltilmiş uzak görme keskinliği), korneal ve konjonktival boyanma (Oxford) skoru, GKZ (gözyaşı kırılma zamanı), Schirmer-2 skoru, OSDI (oküler yüzey hastalık indeksi) skoru, GİB (göziçi basıncı), günlük suni gözyaşı kullanım miktarı, araştırmacının global tedavi cevabını değerlendirmesi ve oküler rahatsızlık için hastanın subjektif değerlendirme skoru. Ayrıca, her muayenede ilaçla ilişkili yan etkiler değerlendirildi. Kuru göz tedavisinin başlangıcında, siklosporinle birlikte topikal %05 loteprednol etabonat kombine edildi. Bulgular: Korneal ve konjonktival boyanma, GKZ, Schirmer-2 değerleri, OSDI skoru, hastanın subjektif değerlendirme skoru ve araştırmacının global tedavi cevabını değerlendirmesi; başlangıç seviyesine kıyasla her vizitte düzelmiş olarak bulundu (p

🔖

Cite This Article

Coşar, C. B., Kılavuzoğlu, A. E., Çelebi, A. R. C., Altıparmak, U. E. (2022). Generic Cyclosporine in the Treatment of Dry Eye Disease. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi, Cilt: 13 - Sayı: 2, 241–246. https://ajindex.com/articles/427400

📄 Full Text PDF Viewer

📄

PDF görüntüleyici hazırlanıyor...

References (13)

  1. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf 2017; 15: 276-83
  2. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf 2017; 15: 575-628
  3. J.M. Barbarino, C.E. Staatz, R. Venkataramanan, T.E. Klein, R.B. Altman. PharmGKB summary: cyclosporine and tacrolimus pathways. Pharmacogenet Genomics 2013; 23: 563-85
  4. E. Donnenfeld, S.C. Pflugfelder. Topical ophthalmic cyclosporine: pharmacology and clinical uses. Surv Ophthalmol 2009; 54: 321-38
  5. S. Matsuda, S. Koyasu. Mechanisms of action of cyclosporine. Immunopharmacology 2000; 47: 119-25
  6. Kunert KS, Tisdale AS, Stern ME, Smith JA, Gipson IK. Analysis of topical cyclosporine treatment of patients with dry eye syndrome: effect on conjunctival lymphocytes. Arch Ophthalmol 2000; 118: 1489-96
  7. Brignole F, Pisella PJ, De Saint Jean M, Goldschild M, Goguel A, Baudouin C. Flow cytometric analysis of inflammatory markers in KCS: 6-month treatment with topical cyclosporine A. Invest Ophthalmol Vis Sci 2001; 42: 90-5
  8. Sullivan BD, Crews LA, Sönmez B, de la Paz MF, Comert E, Charoenrook V, et al. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea 2012; 31: 1000-8
  9. Gao J, Sana R, Calder V, Calonge M, Lee W, Wheeler LA, et al. Mitochondrial permeability transition pore in inflammatory apoptosis of human conjunctival epithelial cells and T cells: effect of cyclosporine A. Invest Ophthalmol Vis Sci 2013; 54: 4717-33
  10. K. Tsubota, H. Fujita, K. Tadano, T. Takeuchi, T. Murakami, I. Saito, et al. Improvement of lacrimal function by topical application of CyA in murine models of Sjögren’s syndrome. Invest Ophthalmol Vis Sci 2001; 42: 101-10
  11. Sall K, Stevenson OD, Mundorf TK, Reis BL. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group, Ophthalmology 2000; 107: 631-9
  12. Pflugfelder SC, De Paiva CS, Villarreal AL, Stern ME. Effects of sequential artificial tear and cyclosporine emulsion therapy on conjunctival goblet cell density and transforming growth factorbeta2 production. Cornea 2008; 27: 64-9
  13. El tayar N, Mark AE, Vallat P, et al. Solvent-dependent conformation and hydrogen-bonding capacity of cyclosporine A: evidence from partition coefficients and molecular dynamics simulations. J Med Chem 1993; 36: