www.arvo.org/Annual_Meeting/2014/Abstracts/2014_Section_Abstract_PDFs/
allez ensuite dans glaucoma puis faites rechercher latanoprostene et voici les deux résultats :
Program Number: 548 Poster Board Number: A0184
Presentation Time: 1:30 PM–3:15 PM
Effcacy of Latanoprostene Bunod Ophthalmic Solution, 0.024%,
in Lowering Intraocular Pressure Over 24-Hours in Normal
Japanese Subjects (KRONUS)
, Tuyen Ong
Ngumah , Jason L. Vittitow , Robert N. Weinreb . Kanto Central
Hospitals, Mutual Aid Assoc of Public Sch Teachers, Setagaya-Ku,
Ophthalmology, University of Tokyo School of Medicine, Japan;
Tokyo, Japan; Clinical Affairs, Bausch+Lomb, Bridgewater, NJ;
Ophthalmology and Hamilton Glaucoma Center, University of
California, San Diego, La Jolla, CA.
Purpose: To evaluate the effect of latanoprostene bunod, 0.024%
in reducing and maintaining IOP over 24 hours in normal Japanese
subjects. In Phase 2 dose-ranging studies in USA (VOYAGER)
and Japan, 0.024% latanoprostene bunod was the safest and most
effcacious dose, demonstrating signifcantly greater IOP reduction
compared with latanoprost, 0.005%.
Methods: This was a single-arm, single-center, open-label, clinical
study of 24 healthy Japanese male volunteers. A baseline IOP profle
was established in both eyes in the sitting position at 8 PM, 10
PM, 12 AM, 2 AM, 4 AM, 8 AM, 10 AM, 12 PM and 4 PM using
a Goldmann applanation tonometer. Following the baseline visit,
both eyes were treated with 0.024% latanoprostene bunod QD at
approximately 8 PM for 14 days. For each subject’s right eye, the
change and change from baseline in sitting IOP at each time point
was assessed on Day 14. A one-sampled paired t-test was used to
determine statistical signifcance.
Results: The mean age of the volunteers was 26.8 (range 20-
39) years. Mean IOPs (± SD) on Day 0 were: 14.4mmHg (1.7),
13.9mmHg (1.5), 13.4mmHg (1.4), 13.0mmHg (1.3), 13.2mmHg
(1.6), 14.0mmHg (1.7), 13.7mmHg (1.5), 13.5mmHg (1.7) and
13.4mmHg (1.6) with a 24-hour mean IOP of 13.6 mmHg (1.6). On
Day 14 pressures were: 11.5mmHg (1.
, 9.8mmHg (1.4), 9.8mmHg
(1.2), 9.9mmHg (1.2), 9.9mmHg (1.5), 9.8mmHg (1.7), 9.6mmHg
(1.3), 9.4mmHg (1.3) and 10.1mmHg (1.1) with a 24-hour mean
IOP of 10.0 mmHg (1.5). Intraocular pressures were taken at 8 PM,
10 PM, 12 AM, 2 AM, 4 AM, 8 AM, 10 AM, 12 PM and 4 PM,
respectively. 14-day QD treatment with 0.024% Latanoprostene
bunod reduced IOP at all time points (p < 0.001) with a mean 24-hour
reduction of 3.6mmHg (1.5) or 26% from the baseline. Peak and
trough IOP lowering occurred at 8 AM and 8 PM (12 and 24 hours
following instillation) with a mean reduction of 4.2mmHg (1.
or
30% and 2.8mmHg (2.2) or 20%, respectively. No signifcant adverse
events were encountered.
Conclusions: Latanoprostene bunod, 0.024% dosed QD for 14 days
signifcantly lowered IOP in normal Japanese subjects during the
entire 24 hour period from 13.6 to 10.0 mmHg, corresponding to 27%
reduction in mean 24-hour IOP. The current result suggests potential
of this compound in providing sustained 24-hour IOP reduction to
glaucoma patients not only with elevated, but also with normal IOP.
Program Number: 3549
Presentation Time: 4:30 PM–4:45 PM
Effcacy of Latanoprostene Bunod Ophthalmic Solution 0.024%
Compared With Timolol Maleate Ophthalmic Solution 0.5%
in Lowering IOP over 24 hours in Subjects With Open Angle
Glaucoma or Ocular Hypertension (CONSTELLATION)
, Jason L. Vittitow , Quintus Ngumah , Robert N. John H. Liu
. Dept of Ophthalmology and Hamilton Glaucoma Center, Weinreb
Univ of California, San Diego, La Jolla, CA; Bausch & Lomb,
Madison, NJ.
Purpose: To compare the effect of latanoprostene bunod (LBN)
0.024% QD with timolol maleate 0.5% BID in reducing 24-hour
intraocular pressure (IOP) in subjects with open angle glaucoma
(OAG) or ocular hypertension (OHT).
Methods: This was a randomized, single-center, open-label, 2-period,
8-week study with crossover at 4 weeks. Twenty subjects (43–82
years) with a baseline IOP at least 22 mmHg in at least 1 eye and less
than 36 mmHg in both eyes and a diagnosis of OAG or OHT were
included. Subjects were housed in a sleep laboratory for 24 hours and
a baseline IOP profle was created. IOP of both eyes was measured
with a pneumatonometer every two hours in the sitting and supine
positions from 8AM to 10PM, and in the supine position only from
12AM to 6AM. During the frst period of the study subjects were
randomized 1:1 to either of 2 treatment sequences: LBN 0.024%
instilled in both eyes at 8PM or timolol maleate 0.5% instilled twice
a day at 8AM and 8PM. After four weeks of treatment, subjects
were housed in the sleep laboratory for a second 24 hour period IOP
measurement. At the end of the 24 hours, subjects were crossed over
to receive the comparator treatment, which initiated period 2. After
four weeks of the period 2 treatment, subjects were housed in the
sleep laboratory for a third 24 hour IOP measurement. The mean IOP
from both periods for the 2 treatment groups (LBN 0.024% QD and
timolol maleate 0.5% BID) were compared using a Mixed Model
Repeated Measures analysis of variance (ANOVA) model, during the
diurnal, nocturnal, and 24 hour periods.
Results: Mean change from baseline in IOP (mmHg) was 3.9±0.28
for latanoprostene bunod treated eyes and 2.4±0.29 for timolol treated
eyes during the diurnal period; 2.75 ± 0.45 for latanoprostene bunod
and 0.2±0.46 for timolol during the nocturnal period; and 3.5 ± 0.24
for latanoprostene bunod and 1.7±0.25 for timolol during the entire
24 hour period.
Conclusions: In this group of open angle glaucoma/ocular
hypertensive patients, LBN 0.024% was shown to be superior to
timolol with regard to IOP lowering during the entire 24 hour period
measured (p<0.05), suggesting that treatment with LBN 0.024% may
provide more effective and better sustained diurnal and nocturnal IOP
reduction.