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Systematic review of randomised clinical trials on topical ciclosporin A for the treatment of dry eye disease
  1. Marta Sacchetti1,
  2. Flavio Mantelli2,
  3. Alessandro Lambiase3,
  4. Alessandra Mastropasqua3,
  5. Daniela Merlo4,
  6. Stefano Bonini3
  1. 1Cornea and Ocular Surface Unit, Ospedale San Raffaele di Milano, IRCCS, Milan, Italy
  2. 2GB Bietti Eye Foudation IRCCS, Rome, Italy
  3. 3Department of Ophthalmology, University Campus Bio-Medico of Rome, Italy
  4. 4Departments of Cell Biology and Neuroscience, Istituto Superiore di Sanità of Rome, Italy
  1. Correspondence to Professor Stefano Bonini, Department of Ophthalmology, University of Rome ‘Campus Bio-Medico’, Via Alvaro del Portillo, 200 00128 Rome, Italy; s.bonini{at}


Aims Topical ciclosporin A (CsA) is a therapeutic option for dry eye disease (DED) to control ocular surface inflammation and improve tear function. The aim of this study is to systematically review data from randomised clinical trials (RCTs) evaluating efficacy and safety of topical CsA treatment for DED.

Methods Articles published up to December 2012 were identified from Medline, Embase and the Cochrane Controlled Trials Register. A total of 18 RCTs that evaluated the efficacy and safety of different topical CsA formulations for the treatment of DED were selected according to the set criteria. The Jadad score was calculated to assess RCT quality.

Results The mean Jadad score of the included RCTs was 2.8±0.6. All CsA formulations proved safe for the treatment of DED. Symptoms improved in 100% (9/9) RCTs, tear function improved in 72% (13/18) RCTs and ocular surface damage was ameliorated in 53% (9/17) RCTs in patients with DED. No improvements with CsA treatment versus control were observed in DED resulting from surgical procedures, contact lens use and thyroid orbitopathy. Statistical comparison of CsA efficacy through a meta-analysis of data was not possible due to a lack of standardised criteria and comparable outcomes among studies.

Conclusions Although topical CsA appears to be a safe treatment for DED, evidence emerging from RCTs is limited, and this affects the strength of recommendations to healthcare providers and policymakers for optimal management. Standardised diagnostic criteria to assess the efficacy of topical CsA are recommended to improve the design of future RCTs in DED.

  • Cornea
  • Conjunctiva
  • Clinical Trial
  • Immunology
  • Ocular surface

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