A randomized trial of topical cyclosporin 0.05% in topical steroid-resistant atopic keratoconjunctivitis

Esen Karamursel Akpek, John K. Dart, Stephanie Watson, William Christen, Dilek Dursun, Sonia H Yoo, Terrence O'Brien, Oliver D. Schein, John D. Gottsch

Research output: Contribution to journalArticle

105 Citations (Scopus)

Abstract

Objective: To evaluate the short-term efficacy and safety of topical cyclosporin A 0.05% in the treatment of patients with severe, steroid-resistant atopic keratoconjunctivitis (AKC). Design: Multicenter, placebo-controlled, double-masked, randomized trial. Participants: Twenty-two patients with AKC refractory to topical steroid treatment. Intervention: Patients were randomly assigned (1:1) to treatment with topical 0.05% cyclosporin A eyedrops or a placebo (artificial tears) for a period of 28 days, 6 times daily during the first 2 weeks and 4 times daily during the last 2 weeks. Main Outcome Measures: Symptoms (itching, tearing, discomfort, mucous discharge, and photophobia) and signs (bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) of AKC recorded on the day of enrollment and at the end of the treatment period. Results: A composite score computed by summing the severity grade over all 5 symptoms and 6 signs of AKC for each patient indicated a greater improvement in the cyclosporin A group relative to the placebo at the end of the 4-week treatment period (P = 0.048 and P = 0.002, for symptoms and signs, respectively). No adverse effects of the treatment with cyclosporin A 0.05% eyedrops were observed. Conclusions: Topical cyclosporin A 0.05% seems to be safe and have some effect in alleviating signs and symptoms of severe AKC refractory to topical steroid treatment.

Original languageEnglish
Pages (from-to)476-482
Number of pages7
JournalOphthalmology
Volume111
Issue number3
DOIs
StatePublished - Mar 1 2004

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Keratoconjunctivitis
Cyclosporine
Steroids
Signs and Symptoms
Ophthalmic Solutions
Placebos
Therapeutics
Blepharitis
Corneal Neovascularization
Allergic Conjunctivitis
Photophobia
Keratitis
Hyperemia
Pruritus
Outcome Assessment (Health Care)
Safety

ASJC Scopus subject areas

  • Ophthalmology

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A randomized trial of topical cyclosporin 0.05% in topical steroid-resistant atopic keratoconjunctivitis. / Akpek, Esen Karamursel; Dart, John K.; Watson, Stephanie; Christen, William; Dursun, Dilek; Yoo, Sonia H; O'Brien, Terrence; Schein, Oliver D.; Gottsch, John D.

In: Ophthalmology, Vol. 111, No. 3, 01.03.2004, p. 476-482.

Research output: Contribution to journalArticle

Akpek, EK, Dart, JK, Watson, S, Christen, W, Dursun, D, Yoo, SH, O'Brien, T, Schein, OD & Gottsch, JD 2004, 'A randomized trial of topical cyclosporin 0.05% in topical steroid-resistant atopic keratoconjunctivitis', Ophthalmology, vol. 111, no. 3, pp. 476-482. https://doi.org/10.1016/j.ophtha.2003.05.035
Akpek, Esen Karamursel ; Dart, John K. ; Watson, Stephanie ; Christen, William ; Dursun, Dilek ; Yoo, Sonia H ; O'Brien, Terrence ; Schein, Oliver D. ; Gottsch, John D. / A randomized trial of topical cyclosporin 0.05% in topical steroid-resistant atopic keratoconjunctivitis. In: Ophthalmology. 2004 ; Vol. 111, No. 3. pp. 476-482.
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abstract = "Objective: To evaluate the short-term efficacy and safety of topical cyclosporin A 0.05{\%} in the treatment of patients with severe, steroid-resistant atopic keratoconjunctivitis (AKC). Design: Multicenter, placebo-controlled, double-masked, randomized trial. Participants: Twenty-two patients with AKC refractory to topical steroid treatment. Intervention: Patients were randomly assigned (1:1) to treatment with topical 0.05{\%} cyclosporin A eyedrops or a placebo (artificial tears) for a period of 28 days, 6 times daily during the first 2 weeks and 4 times daily during the last 2 weeks. Main Outcome Measures: Symptoms (itching, tearing, discomfort, mucous discharge, and photophobia) and signs (bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) of AKC recorded on the day of enrollment and at the end of the treatment period. Results: A composite score computed by summing the severity grade over all 5 symptoms and 6 signs of AKC for each patient indicated a greater improvement in the cyclosporin A group relative to the placebo at the end of the 4-week treatment period (P = 0.048 and P = 0.002, for symptoms and signs, respectively). No adverse effects of the treatment with cyclosporin A 0.05{\%} eyedrops were observed. Conclusions: Topical cyclosporin A 0.05{\%} seems to be safe and have some effect in alleviating signs and symptoms of severe AKC refractory to topical steroid treatment.",
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AU - Dart, John K.

AU - Watson, Stephanie

AU - Christen, William

AU - Dursun, Dilek

AU - Yoo, Sonia H

AU - O'Brien, Terrence

AU - Schein, Oliver D.

AU - Gottsch, John D.

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N2 - Objective: To evaluate the short-term efficacy and safety of topical cyclosporin A 0.05% in the treatment of patients with severe, steroid-resistant atopic keratoconjunctivitis (AKC). Design: Multicenter, placebo-controlled, double-masked, randomized trial. Participants: Twenty-two patients with AKC refractory to topical steroid treatment. Intervention: Patients were randomly assigned (1:1) to treatment with topical 0.05% cyclosporin A eyedrops or a placebo (artificial tears) for a period of 28 days, 6 times daily during the first 2 weeks and 4 times daily during the last 2 weeks. Main Outcome Measures: Symptoms (itching, tearing, discomfort, mucous discharge, and photophobia) and signs (bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) of AKC recorded on the day of enrollment and at the end of the treatment period. Results: A composite score computed by summing the severity grade over all 5 symptoms and 6 signs of AKC for each patient indicated a greater improvement in the cyclosporin A group relative to the placebo at the end of the 4-week treatment period (P = 0.048 and P = 0.002, for symptoms and signs, respectively). No adverse effects of the treatment with cyclosporin A 0.05% eyedrops were observed. Conclusions: Topical cyclosporin A 0.05% seems to be safe and have some effect in alleviating signs and symptoms of severe AKC refractory to topical steroid treatment.

AB - Objective: To evaluate the short-term efficacy and safety of topical cyclosporin A 0.05% in the treatment of patients with severe, steroid-resistant atopic keratoconjunctivitis (AKC). Design: Multicenter, placebo-controlled, double-masked, randomized trial. Participants: Twenty-two patients with AKC refractory to topical steroid treatment. Intervention: Patients were randomly assigned (1:1) to treatment with topical 0.05% cyclosporin A eyedrops or a placebo (artificial tears) for a period of 28 days, 6 times daily during the first 2 weeks and 4 times daily during the last 2 weeks. Main Outcome Measures: Symptoms (itching, tearing, discomfort, mucous discharge, and photophobia) and signs (bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) of AKC recorded on the day of enrollment and at the end of the treatment period. Results: A composite score computed by summing the severity grade over all 5 symptoms and 6 signs of AKC for each patient indicated a greater improvement in the cyclosporin A group relative to the placebo at the end of the 4-week treatment period (P = 0.048 and P = 0.002, for symptoms and signs, respectively). No adverse effects of the treatment with cyclosporin A 0.05% eyedrops were observed. Conclusions: Topical cyclosporin A 0.05% seems to be safe and have some effect in alleviating signs and symptoms of severe AKC refractory to topical steroid treatment.

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