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External Diseases Free Papers 70th AIOC Proceedings, Cochin 2012 EXTERNAL DISEASES Role of Tacrolimus Ointment (0.03%) in Refractory Vernal Keratoconjunctivitis (VKC) and Dry Eye -----------------------------------------------------------------------------550 Dr. Sheetal Deolekar, Dr. Samar Kumar Basak, Dr. Sanjib Banerjee Surgical Management of SINS (Surgically Induced Necrotising Scleritis) -----553 Dr. Uma Sridhar Tacrolimus 0.03% Ointment for Seborrhoeic Blepharitis-An Open Label Pilot Study -----------------------------------------------------------------------------------------------556 Dr. Saswata Biswas, Dr. Santanu Mitra Conjunctival Telangiectasia Mimicking as Conjunctivitis in A Child With Port-Wine (PW) Stain -------------------------------------------------------------------------559 Dr. Anup Kumar Goswami, Dr. Col. B.L.Goswami Autoblood as Tissue Adhesive for Conjunctival Autograft Fixation in Pterygium Surgery ---------------------------------------------------------------------------562 Dr. Santanu Mitra, Dr. Samar K Basak, Dr. Debasish Bhattacharya Controlled Trial of Cyclosporine Versus Olopatadine Topically in Treatment of Vernal Keratoconjuntivitis --------------------------------------------------------------566 Dr. (Mrs.) Eva Tirkey, Dr. (Prof) M. K. Rathore, Dr. (Mrs.) Shashi Jain, Dr. S.C.L. Chandravanshi Active Pulmonary Tuberculosis Presenting with Phlyctenular Keratoconjunctivitis --------------------------------------------------------------------------568 Dr. Minu Ramakrishnan Critical Evaluation and Management of Epibulbar Dermoid ------------------- 570 Dr. Anita Panda, Dr. Anoop, Dr. Sasikala NK Comparison of Carboxymethylcellulose with and without Osmoprotective Agents in Dry Eyes ---------------------------------------------------------------------------- 573 Dr. Gupta P, Dr. Jain M, Dr. Jain R and Dr. D’Souza P. Unusual OSSN – Role of Radio-Imaging. Where are we Today? -------------582 Dr. Rama Rajagopal, Dr. Ravi Daulat Barbhaya, Dr. Bipasha Mukherjee, Dr. Olma Veena Noronha, Dr. Krishna Kumar S. 442 70th AIOC Proceedings, Cochin 2012 EXTERNAL DISEASE Chairman: Dr. Vemuganti Geeta Kashyap; Co-Chairman: Dr. Satyamurthy K.V. Convenor: Dr. Shreesh Kumar K.; Moderator: Dr. Ayan Mohanta Role of Tacrolimus Ointment (0.03%) in Refractory Vernal Keratoconjunctivitis (VKC) and Dry Eye Dr. Sheetal Deolekar, Dr. Samar Kumar Basak, Dr. Sanjib Banerjee KC is a chronic ,bilateral conjunctival inflammatory condition common in Vindividuals with atopic background. The disease itself and its treatment with long-term topical steroids can cause significant complications and are potentially blinding. The current treatment modalities include topical steroids, mast cell stabilizers and antihistamines. Though topical steroids can bring relief of symptoms they need to be tapered quickly to avoid cataract and glaucoma but the recurrent and chronic nature of disease leads to prescribing steroids for very long duration by many of the ophthalmologists. The incidence of visual loss due to steroid induced glaucoma varies from 2%1 to 7.69%2 in two series. The incidence of visual loss secondary to steroid induced cataract was 15.32% in the same series.2 Dry eye is a multi factorial disease and the current management includes tear substitutes as the mainstay of treatment. Cyclosporin A, a calcineurin inhibitor is being used as anti-inflammatory agent and is not associated with any significant ocular or systemic adverse reaction. Perry et. al. demonstrated better results in improvement of dry eye disease signs in severe disease than mild to moderate disease.3 The main factor limiting widespread use of this drug is the high cost of the available preparations. Tacrolimus (FK-506) is a strong immunosuppressant that inhibits the proliferative response of lymphocytes to alloantigen stimulation and a variety of T cell associated immune reactions. It has been isolated from the fermentation broth of Streptomyces tsukubaenis. Tacrolimus suppresses the immune responses by inhibiting the inflammatory cytokine release e.g.( , interleukin-2, IL-3, IL-4, IL-5, IL-8, interferon-gamma, tumor necrosis factor-α) and also down-regulates the high-affinity IgE receptor I (FcRI) expression on Langerhans cells.4 Tacrolimus shares several immunosuppressive properties with cyclosporine A, although it is known to be 10 to 100 times more potent in this regard.5 Its safety and efficacy in the treatment of atopic dermatitis have been demonstrated in short- and long-term studies with adult and pediatric patients.6 The purpose of this study is to evaluate efficacy and safety of off label 550 External Diseases Free Papers tacrolimus skin ointment 0.03% in severe VKC and dry eye refractory to conventional therapy. MATERIALS AND METHodS Patients were divided into two groups according to disease Group A VKC and Group B Severe dry eye. Group-A: 20 eyes of 10 patients of severe VKC with papillae (>5 each>3 mm). All patients were known to have had a long-standing VKC that was previously treated with steroid eye drops. Some of them presented elevation of the intraocular pressure and cataract due to previous steroid treatment or were refractory to the standard steroid regime. None of the patients had a history of chemical, thermal, radiation injury, bacterial, viral or toxic cicatrical conjunctivitis, or underwent any ocular surgery that would create an ocular surface problem. Group-B: 10 eyes of 5 patients with severe dry eye (Schirmer<5mm, Rose Bengal score>4) None of these patients were on topical cyclosporine before starting tacrolimus. One of the patient had severe dry eye secondary to Steven Johnson syndrome. Tacrolimus ointment 0.03% (Tacroz, Glenmark Pharma) was advised twice daily. The dermatological ointment available in the market was attached with the specially designed nozzle to deliver intended quantity of the drug (5 mm ribbon). (Figure 1). Followup was done on day 7, 30, 60 and 90. Figure 1: Specially designed nozzle Both groups evaluated by symptom score attached to dermatological ointment and serial photographs in Gr-A and tear function tests in Gr-B. Adverse reactions if any were noted. ReSULTS All patients completed the study. Two of five dry eye patients complain of burning or heat sensation, the most common adverse effects of the tacrolimus ointment which resolved over a period of 2 weeks. None of the patients presented episode of herpetic keratitis during the treatment with tacrolimus. No significant changes in the intraocular pressure, cornea, lens, refraction or anterior chamber occurred in any patients during the treatment with 551 70th AIOC Proceedings, Cochin 2012 topical tacrolimus. Significant subjective improvement in itching, photophobia was observed and objectively significant decrease in the size of papillae on anterior segment photography and inflammation on slit lamp examination was noticed.. Two representative cases of improvement in clinical findings in limbal and tarsal papillae after 1 month of treatment with tacrolimus is shown (Figure 2,3). Group-B: Improved Schirmer and Rose Bengal score (p<0.05% used student t test) DISCUSSION Tacrolimus is an approved drug for atopic dermatitis; it has an immunosuppressive effect in the inflammatory cascade. Currently, there are 2 FDA-approved concentrations of tacrolimus—0.1% and Figure 2: Pre and Post treatment VKC 0.03% (for children under 2 years of age). limbal form at 1 month Recent studies in children showed that both concentrations of tacrolimus are safe and effective for use in moderate to severe atopic dermatitis. PMK Tam et. al. have also shown topical tacrolimus as effective monotherapy in VKC.7 For ophthalmic use, topical tacrolimus ointment has been used in atopic keratoconjuctivitis, blepharo keratoconjunctivitis, chronic follicular conjunctivitis, and vernal keratoconjuctivitis. Herpes simplex keratitis was reported as a potential adverse effect of topical tacrolimus in the case series described by Joseph et. al.8 Studies in animals have proved that topical tacrolimus increases aqueous tear secretion and can be used in Figure 3: Reduction in size of papillae keratoconjunctivitis sicca refractory to post treatment at 1 month. cyclosporine9 but it was not used in humans in past. Our study shows significant improvement in shirmers test accompanied by subjective improvement and improved visual acuity. 552 External Diseases Free Papers In conclusion tacrolimus skin ointment is safe, effective and well tolerated in severe VKC and refractory dry eye. It may be considered as an alternative to steroid or cyclosporine in both cases. Future prospective studies with further follow-up and more cases are necessary regarding the long-term efficacy of this therapeutic approach for patients with VKC and refractory dry eye. REFERENceS 1. Bonini S, Lambaise A, Marchi S et. al. Vernal keratoconjunctivitis revised: a case series of 195 patients with long-term follow-up. Ophthalmology. 2000;107:1157-63. 2. Tabbara KF. Ocular complications of vernal keratoconjunctivitis. Can J Ophthalmol. 1999;34:88-92 3. Perry HD, Solomon R, Donnenfeld ED et. al. Evaluation of topical cyclosporine for the treatment of dry eye disease. Arch Ophthalmol. 2008;126:1046-50. 4. Reitamo S, Remitz A, Kyllonen H, Saarikko J. Topical noncorticosteroid immunomodulation in the treatment of atopic dermatitis. Am J. Clin Dermatol. 2002;3:381–8. 5. Ezeamuzie CI. Anti-allergic activity of cyclosporin-A metabolites and their interaction with the parent compound and FK 506. Int J. Immunopharmacol. 1996;18:263–70. 6. Kang
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