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John H K Liu, Jason L Vittitow, Quintus Ngumah, Robert N Weinreb; Efficacy 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). Invest. Ophthalmol. Vis. Sci. 2014;55(13):3549.
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© ARVO (1962-2015); The Authors (2016-present)
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).
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 profile 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 first 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.
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.
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.
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