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Safety and efficacy of 4-terpineol against microorganisms associated with blepharitis and common ocular diseases

OBJECTIVE: Microbial infection has been reported to cause blepharitis, conjunctivitis and keratitis. We evaluated the safety and efficacy of a foam formulation of 2% 4-terpineol (T4O) against common ocular microorganisms. MATERIAL AND METHODS: The antimicrobial effect of a 2% T4O formulation was eva...

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Detalles Bibliográficos
Autores principales: Su, Chen-Wei, Tighe, Sean, Sheha, Hosam, Cheng, Anny M S, Tseng, Scheffer C G
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6093255/
https://www.ncbi.nlm.nih.gov/pubmed/30123842
http://dx.doi.org/10.1136/bmjophth-2017-000094
Descripción
Sumario:OBJECTIVE: Microbial infection has been reported to cause blepharitis, conjunctivitis and keratitis. We evaluated the safety and efficacy of a foam formulation of 2% 4-terpineol (T4O) against common ocular microorganisms. MATERIAL AND METHODS: The antimicrobial effect of a 2% T4O formulation was evaluated by the United States Pharmacopeia 51 (USP <51>) antimicrobial effectiveness test for 14 and 28 days, as well as by a Time Kill Study (ASTM E2315) with a 60 s exposure time. Its potential of causing skin and ocular irritation was evaluated by the Repeated Insult Patch Test and the Hen’s Egg Chorioallantoic Membrane Test, respectively. RESULTS AND DISCUSSION: It was seen that 2% T4O formulation did not cause ocular irritation, skin irritation, sensitisation or allergic contact dermatitis in human subjects. Most importantly, it killed microorganisms listed in USP <51> at both 14 and 28 days and exerted a rapid killing effect within 60 s against 13 bacteria, 1 fungus and Acanthamoeba castellanii. CONCLUSION: The above finding suggests that 2% T4O formulation is safe and effective in killing microorganisms related to common ocular and skin infective diseases. TRANSLATIONAL RELEVANCE: Although the clinical efficacy in treating ocular disease was not directly studied; this foam formulation containing 2% T4O, based on the in vitro results of this work, demonstrated that it can potentially be used as a preservative-free cleansing agent for ocular hygiene maintenance due to its ability to exert a broad-spectrum antimicrobial effect without causing ocular or skin irritation.