Comparison of the toxicity profile of benzalkonium chloride-preserved tafluprost and SofZia-preserved travoprost applied to the ocular surface.

Abstract

PURPOSE:

To evaluate some clinically important features of benzalkonium chloride (BAK) toxicity by comparing tafluprost with 0.001% BAK and travoprost preserved with SofZia applied to the ocular surface of the eyes with glaucoma.

METHODS:

This was a prospective, randomized, observer unmasked, multicenter crossover trial. A total of 195 patients were randomized and 174 patients completed the study at 19 clinics between November 2011 and August 2012. Topical BAK-preserved tafluprost or SofZia-preserved travoprost was newly administered or continued. Superficial punctate keratopathy (SPK), tear break-up time (BUT), the conjunctival hyperemia score, and intraocular pressure (IOP) were compared at the baseline visit, 4, and 12 weeks after the start of therapy. The eye drops were switched to another eye drop after 12 weeks of observation.

RESULTS:

The total SPK and conjunctival hyperemia scores were significantly lower in the tafluprost compared with those in the travoprost phase (both P=0.038). There were no significant differences in the SPK scores of the superior area (P=0.679), central area (P=0.089), inferior area (P=0.090), and tear BUT (P=0.271). The IOP-lowering effects were similar (P=0.155).

CONCLUSIONS:

SPK, hyperemia score, and tear BUT while using tafluprost with 0.001% BAK were not inferior compared with those caused by travoprost with SofZia.

• Authors: Takashi Kanamoto, Yoshiaki Kiuchi, Masaki Tanito, Shiro Mizoue, Tomoko Naito, Shinichiro Teranishi, Kazuyuki Hirooka, Ulfah Rimayanti, Ocular Surface Disease and Glaucoma Study Group
• Journal: Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics (J Ocul Pharmacol Ther) Vol. 31 Issue 3 Pg. 156-64 (Apr 2015) ISSN: 1557-7732 [Electronic] United States
• PMID: 25710276 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antihypertensive Agents
• Benzalkonium Compounds
• Ophthalmic Solutions
• Preservatives, Pharmaceutical
• Prostaglandins F
• tafluprost
• Travoprost

Topics

• Aged
• Antihypertensive Agents (administration & dosage, adverse effects, chemistry)
• Benzalkonium Compounds (adverse effects, chemistry)
• Cross-Over Studies
• Female
• Glaucoma, Open-Angle (drug therapy, pathology)
• Humans
• Intraocular Pressure (drug effects)
• Male
• Ocular Hypertension (drug therapy, pathology)
• Ophthalmic Solutions (administration & dosage, adverse effects, chemistry)
• Preservatives, Pharmaceutical (adverse effects, chemistry)
• Prospective Studies
• Prostaglandins F (administration & dosage, adverse effects, chemistry)
• Travoprost (administration & dosage, adverse effects, chemistry)