@article {Sue000094, author = {Chen-Wei Su and Sean Tighe and Hosam Sheha and Anny M S Cheng and Scheffer C G Tseng}, title = {Safety and efficacy of 4-terpineol against microorganisms associated with blepharitis and common ocular diseases}, volume = {3}, number = {1}, elocation-id = {e000094}, year = {2018}, doi = {10.1136/bmjophth-2017-000094}, publisher = {BMJ Specialist Journals}, abstract = {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{\textquoteright}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.}, URL = {https://bmjophth.bmj.com/content/3/1/e000094}, eprint = {https://bmjophth.bmj.com/content/3/1/e000094.full.pdf}, journal = {BMJ Open Ophthalmology} }