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

The Ocular Surface Disease and Glaucoma Study Group, Rieko Ishihara

Research output: Contribution to journalArticle

10 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)156-164
Number of pages9
JournalJournal of Ocular Pharmacology and Therapeutics
Volume31
Issue number3
DOIs
Publication statusPublished - Apr 1 2015

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Benzalkonium Compounds
Hyperemia
Tears
Ophthalmic Solutions
Intraocular Pressure
Glaucoma
Cross-Over Studies
Multicenter Studies
Observation
Travoprost
tafluprost

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Ophthalmology
  • Pharmacology

Cite this

Comparison of the toxicity profile of benzalkonium chloride-preserved tafluprost and sofzia-preserved travoprost applied to the ocular surface. / The Ocular Surface Disease and Glaucoma Study Group; Ishihara, Rieko.

In: Journal of Ocular Pharmacology and Therapeutics, Vol. 31, No. 3, 01.04.2015, p. 156-164.

Research output: Contribution to journalArticle

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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.",
author = "{The Ocular Surface Disease and Glaucoma Study Group} and Takashi Kanamoto and Yoshiaki Kiuchi and Masaki Tanito and Shiro Mizoue and Tomoko Naito and Shinichiro Teranishi and Kazuyuki Hirooka and Ulfah Rimayanti and Hideki Mochizuki and Shunsuke Nakakura and Ishida Yasuhito and Teranishi Shinichiro and Ken Sagara and Kuniisa Shinkawa and Miho Enoki and Masako Nakayama and Makiko Yuta and Miho Fukumura and Takashi Murashige and Shinichi Okuma and Koji Namiguchi and Naoki Komatsu and Rieko Ishihara and Rieko Ishihara and Tetsuya Baba and Masanobu Mizote",
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AU - The Ocular Surface Disease and Glaucoma Study Group

AU - Kanamoto, Takashi

AU - Kiuchi, Yoshiaki

AU - Tanito, Masaki

AU - Mizoue, Shiro

AU - Naito, Tomoko

AU - Teranishi, Shinichiro

AU - Hirooka, Kazuyuki

AU - Rimayanti, Ulfah

AU - Mochizuki, Hideki

AU - Nakakura, Shunsuke

AU - Yasuhito, Ishida

AU - Shinichiro, Teranishi

AU - Sagara, Ken

AU - Shinkawa, Kuniisa

AU - Enoki, Miho

AU - Nakayama, Masako

AU - Yuta, Makiko

AU - Fukumura, Miho

AU - Murashige, Takashi

AU - Okuma, Shinichi

AU - Namiguchi, Koji

AU - Komatsu, Naoki

AU - Ishihara, Rieko

AU - Ishihara, Rieko

AU - Baba, Tetsuya

AU - Mizote, Masanobu

PY - 2015/4/1

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N2 - 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.

AB - 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.

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