Safety and efficacy of 4-terpineol against microorganisms associated with blepharitis and common ocular diseases. Issue 1 (4th June 2018)

• Record Type: Journal Article
• Authors: Su, Chen-Wei; Tighe, Sean; Sheha, Hosam; Cheng, Anny M S; Tseng, Scheffer C G
• Is Part Of: BMJ open ophthalmology. Volume 3:Issue 1(2018)
• Publication Date: 2018-06-04
• Subjects: microbiology -- infection -- inflammation -- eye lids; Ophthalmology -- Periodicals; 617.7005
• DOI: 10.1136/bmjophth-2017-000094
• Languages: English
• ISSNs: 2397-3269

Abstract

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'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.