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Ciclosporina topica 0,05%

(Restasis, Allergan)

Ojo seco

Ojo seco cronico: inflamacin mediada por


Linfocitos T es clave.
Terapia anti-inflamatoria (corticoides)
mejoran signos y sintomas, pero tienen
RAM`s Arch Soc Esp Oftamol 2000;75:751-6
CsA disminuye inflamacin de glandulas y
superficie ocular, aumentando produccin
lacrimal.
Restasis es bien tolerado (17% escozor, 5
de 293 abandonaron por RAM) y niveles
plasmaticos son indetectables. Ophtalmology
2000;107:631-9

Ojo seco

Inclusin:

Ojo seco moderado a severo (BUT, QPS,


sintomas, schirmer con anestesia <5)
Respuesta insuficiente a lubricacin

Exclusin:

Ojo seco muy severo (schimer <3)


Infeccin activa
Lentes de contacto

Ojo seco

Dosis: 2 veces/dia
Duracin: indefinida (se han seguido
pacientes hasta por 72 meses, sin
RAM)
Podria mejorar definitivamente a un
subgrupo de pacientes tras al menos
6 meses de tto Ophthalmology. 2007
Jan;114(1):76-9

Ojo seco

Compatible con lagrimas artificiales


No mejor pacientes con tapones
punctales o con antiinflamatorios
sistemicos
Buen cumplimiento (79%) y satisfaccin
(7.5/10) Clin Ther. 2006 Nov;28(11):1848-56.
5884 pacientes. 30% mejor en 1 semana,
73% en 3 semanas Curr Med Res Opin. 2005 Jul;21(7):105763

CsA 0,05+lagrimas v/s


Lagrimas en ojo seco + LASIK

Lagrimas v/s CsA 0,05 + lagrimas


iniciado 1 mes antes de LASIK,
suspendido 48h post LASIK, reiniciado y
mantenido 3 meses .
Ambos grupos mejoraron ojo seco, pero
CsA obtuvo resultado refractivo
significativamente mas cercano al
objetivo a los 3 y 6 meses post LASIK (P
= .007) J Cataract Refract Surg. 2006 May;32(5):7728

Queratoconjuntivitis vernal

Multiple studies on the efficacy of topical CsA for treating


vernal keratoconjunctivitis have consistently shown a
beneficial effect of the drug. The improvement took an
average of 2 weeks using 1% or 2% CsA in oil solvents, four
times daily. The duration of treatment depends on the
activity of the inflammation. A rebound phenomenon
occurred soon after discontinuation of the treatment,
indicating the need for a slow taper. Br. J. Ophthalmol., Oct
2005; 89: 1363 - 1367.

The most effective drugs, steroids, should however be


carefully administered, and only for brief periods, to avoid
secondary development of glaucoma. A 2% solution of
cyclosporine in olive oil or in castor oil should be considered
as an alternative. Eye. 2004 Apr;18(4):345-51

Queratoconjuntivitis atpica

Two prospective, randomised, double masked, placebo controlled


trials, topical CsA was found to be an effective and safe treatment in
both steroid dependent and steroid resistant cases of atopic
keratoconjunctivitis Br. J. Ophthalmol., Oct 2005; 89: 1363 - 1367.

21 patients used either topical 2% CsA or the vehicle alone four times daily
for 3 months, in addition to their usual therapy with topical corticosteroids
and/or mast cell stabilisers. The great majority of the treated patients were
able to discontinue their topical steroid treatment.
20 patients with topical steroid resistant, severe atopic
keratoconjunctivitis; they had moderately active disease despite topical
steroid therapy with or without mast cell stabilisers (nedocromil,
lodoxamide). Treatment (CsA or placebo) lasted for 28 days with a dosing
schedule of six times daily during the first 2 weeks and four times daily
during the last 2 weeks. Significant improvement was observed in the CsA
group, and none of these patients had a worsening of the disorder, in
contrast with the placebo group

Topical CsA seems to be an effective steroid sparing agent in patients


with severe atopic keratoconjunctivitis. However, its efficacy as a first
line agent during long term treatment warrants additional studies.

Randomised controlled trial of topical


ciclosporin A in steroid dependent allergic
conjunctivitis.
Br J Ophthalmol. 2006 Apr;90(4):461-4.

Prospective, randomised, double masked, placebo


controlled trial comparing signs, symptoms, and the ability
to reduce or stop concurrent steroid in steroid dependent
atopic keratoconjunctivitis and vernal keratoconjunctivitis
using 0.05% topical ciclosporin A v/s placebo.
40 patients, 18 with atopic keratoconjunctivitis and 22 with
vernal keratoconjunctivitis
No statistical significant difference in drug score,
symptoms, or clinical signs scores between the placebo and
ciclosporin group
No RAM`s

Topical cyclosporine in the management of


shield ulcers.
Cornea. 2004 Mar;23(2):194-200.

2%-0.05% (decreasing concentration) QID topical


cyclosporine in the treatment of 4 cases of severe,
corticosteroid-resistant, vernal keratoconjunctivitis
with shield ulcers.
Healing of ulcers occurred in 10 days with the 2%
concentration in all cases. No side effects except
for a burning sensation during administration.
Recurrences occurred when the concentration was
decreased to 0.05% in 3 cases. The recurrences
were effectively treated with 1% concentration in
all cases, and patients were stable with this
concentration for at least 6 months.

Topical cyclosporine A in severe steroid-dependent


childhood phlyctenular keratoconjunctivitis.
Am J Ophthalmol. 2006 Jan;141(1):62-66.

Children (13 eyes, mean age 9 years) with phlyctenular


keratoconjunctivitis associated with severe steroid-dependent
corneal inflammation and not responding to oral antibiotics
(cyclines or erythromycin)
Topical CsA 2% four times daily, initially combined with topical
dexamethasone for the first week. Cyclosporinemia was
determined every 3 months
Inflammation was controlled in all the eyes within 14 days .
Inflammation did not recur during CsA monotherapy, during a
mean follow-up of 12 +/- 8 months
CsA therapy was stopped in eight patients (10 eyes) after a mean
treatment duration of 13 +/- 9 months (range, 6 to 31 months),
and no recurrences occurred during 10 +/- 3 months of follow-up
Local tolerance of CsA was good. None of the patients had
detectable CsA blood levels. CsA was withdrawn in one case after
6 months, because of generalized skin rash

Queratitis central o paracentral


no infecciosa

Immune mediated, sterile central or paracentral corneal


ulceration may develop in patients with connective tissue
disease, most commonly in rheumatoid arthritis or
Sjgrens disease. These conditions need to be
distinguished from peripheral ulcerative keratitis (PUK),
because PUK is essentially a vasculitis of limbal blood
vessels and is considered to be associated with
(re)activation of systemic illness. Unlike PUK, the
central/paracentral ulcerations may not respond well to
systemic immunosuppressive therapy.
Several small, uncontrolled case series have reported the
beneficial effect of topical CsA in treating paracentral
corneal ulcers associated with connective tissue disease.
(2% or 0.5% CsA, four to six times daily) Br. J. Ophthalmol., Oct
2005; 89: 1363 - 1367.

Otras indicaciones segun


BJO

Queratitis punctata superficial de Thygeson : safe


alternative, particularly for patients who will require
long term topical steroid treatment.
Conjuntivitis leosa: small, uncontrolled case
indicated improvement in refractory LC.
Liquen plano conjuntival:Because of its ability to
accelerate apoptosis in fibrotic tissues, topical CsA
alone was used in a few patients having conjunctival
involvement from lichen planus, and proved
effective in controlling inflammation and scarring
Conjuntivitis limbica superior: topical CsA may be
used for both increasing tear production and
controlling inflammation.

Prevencin rechazo transplante


corneal

52 Tx de bajo riesgo.
CsA 0,05% iniciada 1-10 semanas post-Tx
1 subgrupo con pulsos prednisolona 1% x
4 x 4 dias, cada 6 semanas
Prednisolona sola: menos rechazo que CsA
CsA sola: menos rechazo que Prednisolona
pulsos + CsA Ophthalmology. 2006 Oct;113(10):1785-90

Rechazo corneal: sin


embargo...

Prevention and treatment of corneal graft rejection: current practice


patterns (2004- The Cornea Society) Cornea. 2006 Apr;25(3):286-90.

All respondents used topical corticosteroids for routine postoperative


management and treatment of endothelial graft rejection.
Prednisolone, in brand or generic form, was used by 37 to 90% for
routine management in various clinical scenarios and 81 to 91% for
various manifestations of graft rejection at all time points; however,
after 6 months, 12 to 26% used loteprednol etabonate for routine
management. For routine management of high-risk grafts, 48% used
topical cyclosporine in addition to prednisolone. Compared with
previous surveys, the use of oral steroids significantly decreased for
the routine management of high-risk corneal transplants, and the use
of subconjunctival steroids decreased for the management of graft
rejection
Topical prednisolone remains the mainstay for the prevention and
treatment of corneal graft rejection; however, the role of newer
agents, loteprednol etabonate and topical cyclosporine, is expanding.

Queratitis estromal que no


responde a prednisolona 1%

12 ojos con QE no necrotizante que no


respondieron a prednisolona 1%/4 semanas
CsA 0,05 BID, retirada rapida de prednisolona
En 10/12 se resolvio la queratitis estromal en
1 mes
Disminucion promedio area QE:

CsA: 2mm
Pred: 0.25

4 pacientes recurrieron al suspender CsA


Ophthalmol. 2006 Apr;141(4):771-2.

Am J

Treatment of HSV-1 stromal keratitis with


topical cyclosporin A: a pilot study.
Graefes Arch Clin Exp Ophthalmol. 1999 May;237(5):435-8.

18 Eyes topical CsA + acyclovir ointment. The drugs were


tapered off gradually.
Keratitis resolved with CsA treatment in 10 of 14 patients
with non-necrotizing keratitis and in 2 of 4 with necrotizing
keratitis. Under CsA therapy, persistent or progressive
inflammation was noted in 6 of the 18 patients. These 6
patients with keratitis improved only with combined
CsA/corticosteroids. Corneal ulcers healed in 4 patients with
topical CsA, and corneal neovascularization improved in a
further 8. Except for toxic epitheliopathy, no further CsA
complications were noted.
HSV stromal keratitis can be treated successfully with CsA
eyedrops, especially in non-necrotizing disease. CsA may be
particularly helpful in the presence of steroid glaucoma,
herpetic corneal ulcers, and to taper off topical
corticosteroids

Queratopatia neurotrofica
temprana

1 paciente con queratitis HSV-1 a


repeticin y queratopatia neurotrofica
secundaria (defecto epitelial puntiforme)
Estuvo 6 meses con LC terapeutica,
lagrimas y antibioticos, sin respuesta.
CsA 0,05 BID: sin defecto epitelial a las 4
semanas. Se elimin LC y ATB. Se
mantiene con Csa y lagrimas. Optometry. 2006
Oct;77(10):503-7

Efficacy of topical cyclosporin 0.05% in the


treatment of posterior blepharitis.
J Ocul Pharmacol Ther. 2006 Feb;22(1):47-53.

Cyclosporin 0.05% ophthalmic emulsion versus tobramycin


0.3%/dexamethasone 0.1%
Posterior blepharitis improved significantly from the initial
study visit with both cyclosporin treatment and
tobramycin/dexamethasone.
Cyclosporin provided greater improvements in Schirmer's
scores (P < 0.001), eyelid health (p<0.015), and tear breakup time (P = 0.018) than tobramycin/dexamethasone after
12 weeks of treatment.
A higher percentage of patients in the cyclosporin treatment
group had improvements in symptoms of blurred vision,
burning, and itching and resolution of lid telangiectasia

Carcinoma escamoso corneal y


conjuntival

2 pacientes con bordes de reseccion


infiltrados: Csa 0,05% QID x 12
semanas + MMC 0.01% QID en 2, 4
y 6 semanas.
No recurrencias a 18 meses Am J
Ophthalmol. 2006 Oct;142(4):673-5

Entonces...

Beneficio indiscutible en ojo seco moderado/severo


Beneficio probable:

Alergias oculares cronicas (Vernal/Atopica)


Queratitis paracentrales no infecciosas
Queratitis estromal no necrotizante
Thygeson
Conjuntivitis limbica superior
Liquen plano conjuntival
Blefaritis posterior
Queratoconjuntivitis flictenular
Conjuntivitis leosa

Interesante: mejoro predictibilidad refractiva LASIK


Unico RAM: escozor 14%.

Indicaciones de Ciclosporina tpica 0,05% (Restasis, Allergan )

1.-Ojo seco (2 veces/dia, duracin indefinida)


-Inclusin:

Ojo seco moderado a severo, con respuesta insuficiente a lubricacin.

-Exclusion:

Ojo seco muy severo (Schirmer con anestesia menor a 3mm)


Infeccin activa
Lentes de contacto
Tapones punctales

2.-Queratoconjuntivitis vernal (4 veces/dia, hasta resolucion inflamacin, inicio de


mejora a las 2 semanas, retirada gradual)

3.-Queratoconjuntivitis atopica (6-4 veces/dia, 1-3 meses)


Disminuye dependencia de corticoides. No est claro uso como 1 linea.

4.-Queratitis central o paracentral no infecciosa (enfermedades del tejido


conectivo como Artritis reumatoide o Sjogren) (4-6 veces/dia, hasta resolucin)

5.-Queratitis punctata superficial de Thygeson


Puede ser una alternativa mas segura que los corticoides.
6.-Conjuntivitis leosa.
7.-Liquen plano conjuntival
8.-Conjuntivitis limbica superior
9.-Queratitis estromal no necrotizante
11.-Queratoconjuntivitis flictenular.
12.-Blefaritis posterior

Efectos secundarios: Escozor en 17% de pacientes. Niveles plasmticos despreciables.