Journal List > J Korean Ophthalmol Soc > v.49(3) > 1008204

Byun, Kim, and Seo: The Short-Term Effect of Topical Cyclosporine A 0.05% in Various Ocular Surface Disorder

Abstract

Purpose

To evaluate the efficacy of topical cyclosporine A 0.05% (Restasis) in the treatment of dry eye symptoms caused by various ocular surface inflammatory disorders.

Methods

Thirty‐ three patients with ocular surface diseases, including 17 with Sjögren syndrome, 8 with meibomian gland dysfunction (MGD), 4 with Thygeson's keratitis, and 4 with atopic keratoconjunctivitis (AKC) were treated with Restasis twice a day for 3 months. During follow‐ up, the symptom severity assessment (burning, itching, foreign body sensation, blurring, photophobia, and pain), TBUT (tear break‐ up time), Schirmer score, frequencies of artificial tear use, onset of symptomatic relief, subjective satisfaction score, and side effects were evaluated.

Results

In patients with Sjögren syndrome, foreign body sensation, blurring, photophobia, and pain were reduced after treatment, and the mean Schirmer score, TBUT increased and frequencies of artificial tear use decreased significantly. In patients with MGD, photophobia was reduced after treatment, TBUT and artificial tear use improved after 2 months, and the Schirmer score increased at 3 months. In patient's with Thygeson's keratitis, foreign body sensation and photophobia reduced, and the Schirmer score was increased at 3 months. No significant changes in symptoms, Schirmer score, or TBUT were observed in patients with AKC. Of all subjects, 55% reported symptomatic relief between 3 and 5 weeks after treatment. The mean satisfaction score after treatment was the highest for patients with Sjögren syndrome. Two subjects reported a temporary burning sensation, and one subject quit using Restasis because of bitter taste and a burning sensation.

Conclusions

Treatment with Restasis appeared to be effective in treating dry eye symptoms in patients with Sjögren syndrome. It was shown to be partially helpful in patients with MGD and Thygeson's keratitis, while it showed no beneficial effect in patients with AKC.

References

1. Behrens A, Doyle JJ, Stern L, et al. Dysfunctional tear syndrome: a Delphi approach to treatment recommendations. Cornea. 2006; 25:900–7.
2. Paik SH, Lee TS. The effect of Punctal Plug on Dry Eye Syndrome. J Korean Ophthalmol Soc. 1994; 35:737–44.
3. Yi JY, Paik HJ. The clinical effect of the silicone intracanalicular plug in dry eye syndrome. J Korean Ophthalmol Soc. 1995; 36:1847–53.
4. Avunduk AM, Avunduk MC, Varnell ED, Kaufman HE. The comparision of efficacies of topical corticosteroids and nonsteroidal anti– inflammatory drops on dry eye patients: A clinical and immunocytochemical study. Am J Ophthalmol. 2003; 136:593–602.
5. Marsh P, Pflugfelder SC. Topical non– preserved methylprednisolone therapy for keratoconjunctivitis sicca in Sjogren's syndrome. Ophthalmology. 1999; 106:811–6.
6. Pflugfelder SC. Antiinflammatory therapy for dry eye. Am J Ophthalmol. 2004; 137:337–42.
crossref
7. O'Brien PD, Collum LM. Dry eye: diagnosis and current treatment strategies. Curr Allergy Asthma Rep. 2004; 43:314–9.
8. Kunert KS, Tisdale AS, Stern ME, et al. Analysis of topical cyclosporine treatment of patients with dry eye syndrome: effect on conjunctival lymphocytes. Arch Ophthalmol. 2000; 118:1489–96.
9. Perry HD, Donnenfeld ED. Topical 0.05% cyclosporine A in the treatment of dry eye. Expert Opin Pharmacother. 2004; 5:2099–107.
10. Brignole F, Pisella P– J, de Saint Jean M, et al. Flow cytometric analysis of inflammatory markers in KCS: 6-month treatment with topical cyclosporine A. Invest Ophthamol Vis Sci. 2001; 42:90–5.
11. Stonecipher K, Perry HD, Gross RH, Kerney DL. The impact of topical cyclosporine A emulsion 0.05% on the outcomes of patients with keratoconjunctivitis sicca. Curr Med Res Opin. 2005; 21:1057–63.
crossref
12. Barber LD, Pflugfelder SC, Tauber J, Foulks GN. Phase III safety evaluation of cyclosporine 0.1% ophthalmic emulsion administered twice daily to dry eye disease patients for up to 3 years. Ophthalmology. 2005; 112:1790–4.
crossref
13. 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.
14. Stevenson D, Tauber J, Reis BL. Efficacy and safety of cyclosporine A ophthalmic emulsion in the treatment of moderate– to– severe dry eye disease: a dose– ranging randomized trial [The cyclosporon A phase 2 Study Group]. Ophthalmology. 2000; 107:967–74.
15. Stern ME, Pflugfelder SC. Inflammation in dry eye. Ocular Surface. 2004; 2:124–30.
crossref
16. Stern ME, Gao J, Siemasko KF, et al. The role of the lacrimal functional unit in the pathophysiology of dry eye. Exp Eye Res. 2004; 78:409–16.
crossref
17. Dogru M, Tsubota K. New insights into the diagnosis and treatment of dry eye. Ocular Surface. 2004; 2:59–75.
crossref
18. Hong S, Kim T, Chung SH, et al. Recurrence after topical nonpreserved methylprednisolone therapy for keratoconjunctivitis sicca in Sjogren's syndrome. J Ocul Phamacol Ther. 2007; 23:78–82.
19. Driver PJ, Lemp MA. Meibomian gland dysfunction. Surv Ophthalmol. 1996; 40:343–67.
crossref
20. Perry HD, Doshi-Carnevale S, Donnefeld ED, et al. Efficacy of commercially available topical cyclosporine A 0.05% in the treatment of meibomian gland dysfunction. Cornea. 2006; 25:171–5.
crossref
21. Rubin M, Rao SN. Efficacy of topical cyclosporin 0.05% in the treatment of posterior blepharitis. J Ocul Pharmacol Ther. 2006; 22:47–53.
crossref
22. Hardten DR, Doughman DJ, Holland EJ, et al. Persistent superficial punctate keratitis after resolution of chlamydial follicular conjunctivitis. Cornea. 1992; 11:360–3.
crossref
23. Rdinhard T, Sundmacher R. Topical cyclosporin A in Thygeson's superficial punctate keratitis. Graefes Arch Clin Exp Ophthalmol. 1999; 237:109–12.
24. Dogru M, Okada N, Asano-Kato N, et al. Alterations of the ocular surface epithelial mucins 1, 2, 4 and the tear functions in patients with atopic keratoconjunctivitis. Clin Exp Allergy. 2006; 36:1556–65.
crossref
25. Kilic A, Gurler B. Topical 2% cyclosporine A in preservative-free artificial tears for the treatment of vernal keratoconjunctivitis. Can J Ophthalmol. 2006; 41:693–8.
26. Hingorani M, Moodaley L, Calder VL. et al. A randomized, placebo– controlled trial of topical cyclosporin A in steroid-dependent atopic keratoconjunctivitis. Ophthalmology. 1998; 105:1715–20.
27. Tang– Liu DD, Acheampong A. Ocular pharmacokinetics and safety of cyclosporin, a novel topical treatment for dry eye. Clin Pharmacokinet. 2005; 44:247–61.
28. Strong B, Farley W, Stern ME, Pflugfelder SC. Topical cyclosporine inhibits conjunctival epithelial apoptosis in experimental murine keratoconjunctivitis sicca. Cornea. 2005; 24:80–5.
crossref
29. Akpek EK, Dart JK, Watson S, et al. A randomized trial of topical cyclosporin 0.05% in topical steroid– resistant atopic keratoconjunctivitis. Ophthalmology. 2004; 111:476–82.
30. Daniell M, Constantinou M, Vu HT, Tralor HR. Randomised controlled trial of topical ciclosporin A in steroid dependent allergic conjunctivitis. Br J Ophthalmol. 2006; 90:461–4.
crossref

Figure 1.
Change in symptom severity ratings before and after Restasis treatment. Six Ocular symptoms (burning, itching, foreign body sensation, blurring, photophobia, pain) were graded from 0 to 4 depending on severity. Average ratings according to patient groups: (A)=Sjogren syndrome; (B)=MGD (Meibomian gland dysfunction); (C)=Thygeson keratitis; (D)=atopic keratoconjunctivitis. ( significantly different from pretreatment, p<0.05)
jkos-49-401f1.tif
Figure 2.
Change of mean schirmer score before and after Restasis treatment. Significantly different from pretreatment, p<0.05.
jkos-49-401f2.tif
Figure 3.
Change of TBUT before and after Restasis treatment. Significantly different from pretreatment, p<0.05.
jkos-49-401f3.tif
Figure 4.
Change of frequencies of artificial tear instillation per day before and after Restasis treatement. Significantly different from pretreatment, p<0.05.
jkos-49-401f4.tif
Figure 5.
Distribution by time from treatment initiation to experience of symptom relief after Restasis instillation.
jkos-49-401f5.tif
Figure 6.
Mean subjective satisfaction score (0 to 10) after completion of 3-month Restasis treatment.
jkos-49-401f6.tif
Table 1.
Patient demograophics
Characteristic Value
Total number of participants completing the study 33
Sex (M:F) 5:28
Mean age 46.0±16.0
Associated disorder (No)  
 Sjögren's syndrome 17
 Meibomian gland dysunction 8
 Thygeson keratitis 4
 Atopic keratoconjunctivitis 4
Used artificial tears prior 10.0±4.0
 (Mean number of times/day)  
 Sjögren's syndrome 12.4±2.7
 Meibomian gland dysfunction 10.8±1.1
 Thygeson keratitis 3.5±1.3
 Atopic keratoconjunctivitis 8.0±2.8
Duration of dry eye symptom (No)  
 <1 years 6
 1–5 years 18
 6–10 years 7
 >10 years 2
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