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Peer-reviewedCC BYFrontiers in ophthalmology

Systematic literature review and meta-analysis of lotilaner 0.25% and tea tree oil for Demodex blepharitis.

  • Ian Benjamin Gaddie1
  • Mayank A Nanavaty2
  • Timothy Page3,4
  • Darrell White5
  • Selina McGee6
  • Pamela E Theriot7
  • Noemi Fluetsch Brennan8
  • Lisa Bloudek8
  • James Mun9
  • Elizabeth Yeu9
  • H Burkhard Dick10
10 affiliations
  1. 1Gaddie Eye Centers, Louisville, KY, United States.
  2. 2Sussex Eye Hospital, University Hospitals Sussex NHS Foundation Trust, Brighton, United Kingdom.
  3. 3Oakland University William Beaumont School of Medicine, Royal Oak, MI, United States.
  4. 4Oakland Ophthalmic Surgery, Birmingham, MI, United States.
  5. 5SkyVision Centers, Westlake, OH, United States.
  6. 6BeSpoke Vision, Edmond, OK, United States.
  7. 7Williamson Azar Vision, Lafayette, LA, United States.
  8. 8Curta Inc, Seattle, WA, United States.
  9. 9Tarsus Pharmaceuticals Inc., Irvine, CA, United States.
  10. 10University Eye Hospital, Ruhr University, Knappschaft Kliniken, Bochum, Germany.
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Abstract

Demodex blepharitis (DB) is a common, often underdiagnosed inflammatory eyelid disease caused by Demodex mite infestation. Currently, the only FDA-approved treatment for DB is lotilaner ophthalmic solution, 0.25%. Off-label therapies, including tea tree oil or terpinen-4-ol (collectively referred to as TTO) products, have also been used; however, supporting evidence is inconsistent. This systematic literature review and meta-analysis evaluated the treatment effects and quality of evidence for lotilaner ophthalmic solution, 0.25% and TTO products in patients with DB. MEDLINE, EMBASE, Cochrane CENTRAL, ClinicalTrials.gov, and ICTRP were searched from inception through July 10, 2025, to identify randomized controlled trials of lotilaner 0.25% or TTO. Nine randomized controlled trials were included, with four evaluating lotilaner 0.25% versus vehicle and five evaluating TTO versus sham, comprising a total of 1,513 patients. Compared with vehicle, lotilaner 0.25% produced significantly lower mite density (mean difference -1.29 mites/lash at both 2-4 and 6-8 weeks; p<0.0001) and significantly higher odds of mite eradication (OR 4.70 at 2-4 weeks; OR 9.60 at 6-8 weeks), collarette reduction to 0-2 collarettes (OR 8.39 and 9.67), and erythema cure at 6-8 weeks (OR 3.91; all p<0.0001). TTO did not demonstrate a statistically significant difference versus sham for mite density or mite eradication at either timepoint. These findings demonstrate a consistent, statistically significant benefit of lotilaner 0.25% across assessed outcomes compared with vehicle, supporting lotilaner 0.25% as an effective pharmacological treatment for DB. In contrast, randomized TTO studies were heterogeneous in product concentration, dosing regimen, and sham comparators and did not demonstrate a statistically significant effect on mite density or mite eradication versus sham comparators.

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Cite

BibTeXRIS
BibTeX
@article{gaddie2026systematic,
  title = {{Systematic literature review and meta-analysis of lotilaner 0.25% and tea tree oil for Demodex blepharitis.}},
  author = {Ian Benjamin Gaddie and Mayank A Nanavaty and Timothy Page and Darrell White and Selina McGee and Pamela E Theriot and Noemi Fluetsch Brennan and Lisa Bloudek and James Mun and Elizabeth Yeu and H Burkhard Dick},
  journal = {Frontiers in ophthalmology},
  year = {2026},
  month = oct,
  doi = {10.3389/fopht.2026.1978403},
  url = {https://europepmc.org/article/MED/42952720},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Systematic literature review and meta-analysis of lotilaner 0.25% and tea tree oil for Demodex blepharitis.
AU  - Ian Benjamin Gaddie
AU  - Mayank A Nanavaty
AU  - Timothy Page
AU  - Darrell White
AU  - Selina McGee
AU  - Pamela E Theriot
AU  - Noemi Fluetsch Brennan
AU  - Lisa Bloudek
AU  - James Mun
AU  - Elizabeth Yeu
AU  - H Burkhard Dick
PY  - 2026
DA  - 2026/10/14
JO  - Frontiers in ophthalmology
DO  - 10.3389/fopht.2026.1978403
UR  - https://europepmc.org/article/MED/42952720
AB  - Demodex blepharitis (DB) is a common, often underdiagnosed inflammatory eyelid disease caused by Demodex mite infestation. Currently, the only FDA-approved treatment for DB is lotilaner ophthalmic solution, 0.25%. Off-label therapies, including tea tree oil or terpinen-4-ol (collectively referred to as TTO) products, have also been used; however, supporting evidence is inconsistent. This systematic literature review and meta-analysis evaluated the treatment effects and quality of evidence for lotilaner ophthalmic solution, 0.25% and TTO products in patients with DB. MEDLINE, EMBASE, Cochrane CENTRAL, ClinicalTrials.gov, and ICTRP were searched from inception through July 10, 2025, to identify randomized controlled trials of lotilaner 0.25% or TTO. Nine randomized controlled trials were included, with four evaluating lotilaner 0.25% versus vehicle and five evaluating TTO versus sham, comprising a total of 1,513 patients. Compared with vehicle, lotilaner 0.25% produced significantly lower mite density (mean difference -1.29 mites/lash at both 2-4 and 6-8 weeks; p<0.0001) and significantly higher odds of mite eradication (OR 4.70 at 2-4 weeks; OR 9.60 at 6-8 weeks), collarette reduction to 0-2 collarettes (OR 8.39 and 9.67), and erythema cure at 6-8 weeks (OR 3.91; all p<0.0001). TTO did not demonstrate a statistically significant difference versus sham for mite density or mite eradication at either timepoint. These findings demonstrate a consistent, statistically significant benefit of lotilaner 0.25% across assessed outcomes compared with vehicle, supporting lotilaner 0.25% as an effective pharmacological treatment for DB. In contrast, randomized TTO studies were heterogeneous in product concentration, dosing regimen, and sham comparators and did not demonstrate a statistically significant effect on mite density or mite eradication versus sham comparators.
SN  - 2674-0826
ER  -