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Peer-reviewedCC BY 4.0Journal of Clinical Medicine

Optimizing Dry Eye Disease Management with Topical Anti-Inflammatory or Immunomodulatory Drugs Combined with Artificial Tears: A Systematic Review and Meta-Analysis of Clinical Trials

  • Eugenia Piragine1
  • Sara Veneziano1
  • Lorenzo Flori2,3
  • Valentina Citi1
  • Marco Sansò4
  • Chiara Posarelli5
  • Alma Martelli1
  • Vincenzo Calderone1
  • Michele Figus5,6
6 affiliations
  1. 1Department of Pharmacy, University of Pisa, via Bonanno 6, 56126 Pisa, Italy
  2. 2Departmental Faculty of Medicine, UniCamillus, Saint Camillus International University of Health Sciences, via di Sant’Alessandro, 8, 00131 Rome, Italy
  3. 3School of Specialization in Hospital Pharmacy, University of Pisa, via Bonanno 6, 56126 Pisa, Italy
  4. 4Istituto Farmaco Biologico Sperimentale (IFBS), via Carducci 64/D, 56017 Pisa, Italy
  5. 5Department of Surgical Medical Molecular Pathology and Critical Care Medicine, University of Pisa, via Paradisa 2, 56124 Pisa, Italy
  6. 6Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia, via Santo Stefano Rotondo 6, 00184 Rome, Italy
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Abstract

Background/Objectives: Dry eye disease (DED) is an ocular condition that significantly impairs quality of life. In mild cases, it is commonly treated with artificial tears (ATs), while more advanced cases are managed with immunomodulatory and anti-inflammatory drugs. The aim of this systematic review and meta-analysis was to evaluate the efficacy and safety of topical anti-inflammatory drugs, immunomodulatory drugs, AT, and their combination in adults with DED. Methods: The protocol was registered in the PROSPERO database (CRD420251245079). Intervention studies were searched in MEDLINE and Scopus databases. Random-effects meta-analyses were performed with the R software (version 4.5.2). Results: A total of 42 studies were included in the meta-analysis of efficacy and 46 in the analysis of safety. Overall, ATs and anti-inflammatory drugs did not produce significant improvements in clinical outcomes compared with controls. Immunomodulatory drugs showed variable results, with inconsistent efficacy and an increased risk of ocular adverse events (AEs). In contrast, combination therapy with ATs significantly improved clinical outcomes, including tear production (mean difference, MD, mm: 1.96, 95% CI [0.58–3.34] for anti-inflammatory drugs and 2.73, 95% CI [0.93; 4.52] for immunomodulatory drugs) and tear break-up time (MD, s: 1.43, 95% CI [0.81; 2.05] for anti-inflammatory drugs and 1.41, 95% CI [0.68; 2.13] for immunomodulatory drugs), without increasing the risk of AEs. Conclusions: Topical combination therapy with anti-inflammatory or immunomodulatory drugs and ATs appears to provide clinical improvements in tear function and patient-reported outcomes in DED, without additional safety concerns compared with ATs alone. These findings support combination treatment as a promising therapeutic strategy.

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Cite

BibTeXRIS
BibTeX
@article{piragine2026optimizing,
  title = {{Optimizing Dry Eye Disease Management with Topical Anti-Inflammatory or Immunomodulatory Drugs Combined with Artificial Tears: A Systematic Review and Meta-Analysis of Clinical Trials}},
  author = {Eugenia Piragine and Sara Veneziano and Lorenzo Flori and Valentina Citi and Marco Sansò and Chiara Posarelli and Alma Martelli and Vincenzo Calderone and Michele Figus},
  journal = {Journal of Clinical Medicine},
  year = {2026},
  month = oct,
  doi = {10.3390/jcm15207801},
  url = {https://www.mdpi.com/2077-0383/15/20/7801},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Optimizing Dry Eye Disease Management with Topical Anti-Inflammatory or Immunomodulatory Drugs Combined with Artificial Tears: A Systematic Review and Meta-Analysis of Clinical Trials
AU  - Eugenia Piragine
AU  - Sara Veneziano
AU  - Lorenzo Flori
AU  - Valentina Citi
AU  - Marco Sansò
AU  - Chiara Posarelli
AU  - Alma Martelli
AU  - Vincenzo Calderone
AU  - Michele Figus
PY  - 2026
DA  - 2026/10/09
JO  - Journal of Clinical Medicine
DO  - 10.3390/jcm15207801
UR  - https://www.mdpi.com/2077-0383/15/20/7801
AB  - Background/Objectives: Dry eye disease (DED) is an ocular condition that significantly impairs quality of life. In mild cases, it is commonly treated with artificial tears (ATs), while more advanced cases are managed with immunomodulatory and anti-inflammatory drugs. The aim of this systematic review and meta-analysis was to evaluate the efficacy and safety of topical anti-inflammatory drugs, immunomodulatory drugs, AT, and their combination in adults with DED. Methods: The protocol was registered in the PROSPERO database (CRD420251245079). Intervention studies were searched in MEDLINE and Scopus databases. Random-effects meta-analyses were performed with the R software (version 4.5.2). Results: A total of 42 studies were included in the meta-analysis of efficacy and 46 in the analysis of safety. Overall, ATs and anti-inflammatory drugs did not produce significant improvements in clinical outcomes compared with controls. Immunomodulatory drugs showed variable results, with inconsistent efficacy and an increased risk of ocular adverse events (AEs). In contrast, combination therapy with ATs significantly improved clinical outcomes, including tear production (mean difference, MD, mm: 1.96, 95% CI [0.58–3.34] for anti-inflammatory drugs and 2.73, 95% CI [0.93; 4.52] for immunomodulatory drugs) and tear break-up time (MD, s: 1.43, 95% CI [0.81; 2.05] for anti-inflammatory drugs and 1.41, 95% CI [0.68; 2.13] for immunomodulatory drugs), without increasing the risk of AEs. Conclusions: Topical combination therapy with anti-inflammatory or immunomodulatory drugs and ATs appears to provide clinical improvements in tear function and patient-reported outcomes in DED, without additional safety concerns compared with ATs alone. These findings support combination treatment as a promising therapeutic strategy.
SN  - 2077-0383
ER  -