Clinical utility of cyclosporine (CsA) ophthalmic emulsion 0.05% for symptomatic relief in people with chronic dry eye: a review of the literature

Figures & data

Table 1 Key papers: CsA for symptomatic relief in chronic dry eye

Study	Title	No. of patients	Population	Treatment	Conclusion
Stevenson et al^Citation27	Efficacy and safety of cyclosporine A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease: a dose-ranging, randomized trial. The Cyclosporin A Phase II Study Group	162	Moderate-to-severe dry eye with or without Sjögren’s syndrome	CsA 0.05%, 0.1%, 0.2%, and 0.4%; versus vehicle	CsA 0.05% produced the most consistent improvement in patient symptoms, but only the 0.2% group had sustained significant improvement in OSDI
Sall et al^Citation32	Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase III Study Group	671	Moderate-to-severe dry eye with or without Sjögren’s syndrome	CsA 0.05% and 0.1%, versus vehicle	CsA 0.05% produced the most reliable subjective improvement and required less rescue AT
Stonecipher et al^Citation45	The impact of topical cyclosporine A emulsion 0.05% on the outcomes of patients with keratoconjunctivitis sicca	5,884	Dry eye diagnosed by the healthcare provider	CsA 0.05%	CsA significantly improved symptom severity by 30% and activity impairment by 31% to 36%; 41% had rapid symptomatic relief response (within 1–3 weeks)
Wilson and Perry^Citation47	Long-term resolution of chronic dry eye symptoms and signs after topical cyclosporine treatment	8	Chronic dry eye	CsA 0.05%	Eight patients studied were cured for at least 1 year after CsA; CsA may prevent progression of dry eye in some patients
Perry et al^Citation29	Evaluation of topical cyclosporine for the treatment of dry eye disease	158	Mild, moderate, and severe dry eye	CsA 0.05%	Greatest improvement in OSDI occurred in mild disease
Rao^Citation37	Topical cyclosporine 0.05% for the prevention of dry eye disease progression	58	Moderate-to-severe dry eye	CsA 0.05% versus vehicle	OSDI scores were significantly better in the CsA group
Chen et al^Citation34	A comparison of cyclosporine 0.05% ophthalmic emulsion versus vehicle in Chinese patients with moderate to severe dry eye disease: an eight-week, multicenter, randomized, double-blind, parallel-group trial	233	Moderate-to-severe dry eye	CsA 0.05% versus vehicle	CsA superiority in symptomatic relief
Rao^Citation46	Reversibility of dry eye deceleration after topical cyclosporine 0.05% withdrawal	48	Moderate-to-severe dry eye	CsA 0.05% versus AT	Earlier CsA treatment resulted in significantly better OSDI; maintenance CsA therapy reduced disease progression
Prabhasawat et al^Citation50	A randomized double-masked study of 0.05% cyclosporine ophthalmic emulsion in the treatment of meibomian gland dysfunction	70	Meibomian gland dysfunction dry eye	CsA 0.05% versus AT	No difference in OSDI
Mah et al^Citation48	PERSIST: Physician’s evaluation of Restasis^® satisfaction in second trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review	35	Chronic dry eye	CsA 0.05%	The second trial success was linked to patient education directly by the physician (97.1%), and simultaneous topical corticosteroid use (28.6%)
Sheppard et al^Citation49	Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%	112	Mild-to-moderate dry eye	Loteprednol etabonate 0.5% or AT prior to CsA 0.05%	Loteprednol etabonate group showed superior results in OSDI improvement

Abbreviations: AT, artificial tears; CsA, cyclosporine; OSDI, ocular surface disease index.

StevensonDTauberJReisBLEfficacy and safety of cyclosporin A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease: a dose-ranging, randomized trial. The Cyclosporin A Phase 2 Study GroupOphthalmology2000107596797410811092

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SallKStevensonODMundorfTKReisBLTwo multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study GroupOphthalmology2000107463163910768324

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StonecipherKPerryHDGrossRHKerneyDLThe impact of topical cyclosporine a emulsion 0.05% on the outcomes of patients with keratoconjunctivitis siccaCurr Med Res Opin20052171057106316004673

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WilsonSEPerryHDLong-term resolution of chronic dry eye symptoms and signs after topical cyclosporine treatmentOphthalmology20071141767917070588

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PerryHDSolomonRDonnenfeldEDEvaluation of topical cyclosporine for the treatment of dry eye diseaseArch Ophthalmol200812681046105018695097

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RaoSNTopical cyclosporine 0.05% for the prevention of dry eye disease progressionJ Ocul Pharmacol Ther201026215716420415623

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ChenMGongLSunXA comparison of cyclosporine 0.05% ophthalmic emulsion versus vehicle in Chinese patients with moderate to severe dry eye disease: an eight-week, multicenter, randomized, double-blind, parallel-group trialJ Ocul Pharmacol Ther201026436136620698799

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RaoSNReversibility of dry eye deceleration after topical cyclosporine 0.05% withdrawalJ Ocul Pharmacol Ther201127660360921999340

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PrabhasawatPTesavibulNMahawongWA randomized double-masked study of 0.05% cyclosporine ophthalmic emulsion in the treatment of meibomian gland dysfunctionCornea201231121386139323135530

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MahFMilnerMYiuSDonnenfeldEConwayTMHollanderDAPERSIST: Physician’s evaluation of Restasis® satisfaction in second trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective reviewClin Ophthalmol201261971197623226002

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SheppardJDDonnenfeldEDHollandEJEffect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%Eye Contact Lens201440528929625083776

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