Safety and Efficacy of Benzalkonium Chloride-optimized Tafluprost in Japanese Glaucoma Patients With Existing Superficial Punctate Keratitis.
OBJECTIVE
To evaluate the safety and efficacy of benzalkonium chloride (BAK)-optimized tafluprost (with a BAK concentration reduced from 0.01% to 0.001%) in glaucoma patients with existing superficial punctate keratitis (SPK).


METHODS
A prospective, multicenter, open-label study was designed to compare BAK-optimized tafluprost administered over 12 weeks relative to other preserved prostaglandin analogs previously administered in Japanese glaucoma patients. Thirty patients with SPK graded at <6 points by area density (AD) scoring in 1 eye were recruited. The primary outcome measure was change in AD score at 12 weeks after the switch in treatment compared with that at baseline. Secondary outcome measures included changes in tear film breakup time (TBUT), hyperemia score, and intraocular pressure (IOP). Four patients were excluded from analysis because of treatment discontinuation.


RESULTS
Mean AD score±SD decreased significantly from 3.4±0.9 to 1.8±1.8 after the switch (P<0.0001). Mean TBUT increased significantly from 6.3±3.3 to 8.0±4.2 seconds (P<0.01). Mean hyperemia score remained unchanged, whereas mean IOP decreased significantly from 15.6±2.6 to 14.4±2.0 mm Hg (P<0.01). For patients previously treated with BAK-preserved latanoprost (n=17) or bimatoprost (n=2), mean AD score decreased significantly from 3.4±0.9 to 1.8±1.8 (P<0.01) and mean TBUT increased significantly from 6.4±3.6 to 8.2±4.3 seconds (P<0.01); no such changes were apparent for patients previously treated with sofZia-preserved travoprost (n=7).


CONCLUSIONS
BAK-optimized tafluprost is a treatment option to improve the condition of the ocular surface and to maintain IOP control in glaucoma patients with existing SPK who have been previously treated with other BAK-preserved prostaglandin analogs.
*Department of Ophthalmology, Graduate School of Medicine, Yamaguchi University **Ube Industires Ltd. Central Hospital, Ube †Sagara Eye Clinic, Hagi ‡Tokuyama Central Hospital, Shunan §Saiseikai Shimonoseki General Hospital ¶Shimonoseki Kousei Hospital ††Toyota Central Hospital, Shimonoseki ∥Ogori Daiichi General Hospital, Yamaguchi #Yamaguchi Grand Medical Center, Hofu, Yamaguchi, Japan.
Katsuyoshi
K
Suzuki
Shinichiro
S
Teranishi
Takeshi
T
Sagara
Hideaki
H
Yoshino
Masako
M
Nakayama
Miho
M
Enoki
Yoshihisa
Y
Nuno
Shinji
S
Hirano
Makiko
M
Wakuta
Norihisa
N
Takahashi
Kayoko
K
Tokuhisa
Yukiko
Y
Kondo
Rie
R
Shiraishi
Yasuhito
Y
Ishida
Koh-Hei
KH
Sonoda
D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D001548:Benzalkonium Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005901:Glaucoma / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D007634:Keratitis / Q000150:complications*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011460:Prostaglandins F / Q000009:adverse effects / Q000627:therapeutic use*; D014065:Tonometry, Ocular
D000959:Antihypertensive Agents; D001548:Benzalkonium Compounds; D011310:Preservatives, Pharmaceutical; D011460:Prostaglandins F; C485333:tafluprost