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Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure.

ABSTRACT: To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP).Prospective, open-label experimental study.Single tertiary ophthalmic clinic.Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years).Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP data were collected under the same laboratory conditions.Diurnal and nocturnal IOP and OPP means under bimatoprost 0.01% treatment were compared with baseline.The diurnal and nocturnal IOP means were significantly lower under the bimatoprost 0.01% treatment than baseline in both the sitting and supine positions. The diurnal and nocturnal OPP means were significantly higher under treatment than baseline in both the sitting and supine positions.Bimatoprost 0.01% monotherapy significantly lowered IOP and increased OPP during the 24 h period.

SUBMITTER: Tung JD

PROVIDER: S-EPMC3951976 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure.

Tung Jonathan D JD Tafreshi Ali A Weinreb Robert N RN Slight J Rigby JR Medeiros Felipe A FA Liu John H K JH

BMJ open 20120823 4

<h4>Objectives</h4>To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP).<h4>Design</h4>Prospective, open-label experimental study.<h4>Setting</h4>Single tertiary ophthalmic clinic.<h4>Participants</h4>Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years).<h4>Interventions</h4>Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Mea ...[more]

PMID: 22918671

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Project description:Medications to control intraocular pressure (IOP) are frequently preserved using benzalkonium chloride (BAK), which can negatively affect the ocular surface. Data are needed to assess efficacy and safety of prostaglandin drugs preserved with and without BAK. The present study compared the efficacy and safety of BAK-free travoprost 0.004% (TRAV) and BAK 0.02%-preserved bimatoprost 0.01% (BIM) during late-day time points in patients with open-angle glaucoma or ocular hypertension.This was a 12-week, phase 4, randomized, investigator-masked, crossover study. 84 patients with IOP ?24 and <36 mmHg were randomized 1:1 to receive once-daily TRAV or BIM for 6 weeks followed by an additional 6-week crossover period. IOP was measured at the end of each treatment period at 4, 6, and 8 pm. TRAV was considered noninferior to BIM if the upper limit of the 95% CI of the between-group difference in mean IOP was ?1.5 mmHg. Adverse events were assessed throughout the study.One patient discontinued due to allergic conjunctivitis, and 2 patients with missing data were excluded; 81 patients were included in the per-protocol population (mean ± SD age, 58.3 ± 11.4 years; TRAV/BIM, n = 41; BIM/TRAV, n = 40). After 6 weeks, mean IOP with TRAV (17.4 ± 2.7 mmHg; change from baseline, -6.0 mmHg) was similar to BIM (17.2 ± 2.6 mmHg; change from baseline, -6.3 mmHg); the between-group difference was 0.22 mmHg (95% CI, -0.22 to 0.67). Thus, noninferiority of TRAV versus BIM was demonstrated. Mean IOP at each time point and mean and percentage IOP change from baseline were not significantly different between treatments. All treatment-emergent adverse events were mild to moderate. The incidences of mild ocular hyperemia with TRAV and BIM were 31% and 39%, respectively; moderate hyperemia was observed in 2% of patients receiving BIM.Late-day IOP-lowering efficacy of BAK-free TRAV was noninferior to that of BAK 0.02%-preserved BIM; both reduced baseline IOP by 25%. Both treatments were well tolerated, although a higher incidence of moderate ocular hyperemia was observed with BIM.ClinicalTrials.gov identifier, NCT01464424; registered November 1, 2011.

Project description:To compare the 24-hour (24h) effects on intraocular pressure (IOP) and cardiovascular parameters of timolol 0.5% and bimatoprost 0.01% in open angle glaucoma and ocular hypertensive subjects.In this prospective, randomized, double masked, crossover, clinical trial, after washout from previous medications enrolled subjects underwent 24h IOP, blood pressure (BP) and heart rate (HR) measurements and were randomized to either topical bimatoprost 0.01% at night plus placebo in the morning or to timolol 0.5% bid. After 8 weeks of treatment a second 24h assessment of IOP, BP and HR was performed and then subjects switched to the opposite treatment for additional 8 weeks when a third 24h assessment was performed. The primary endpoint was the comparison of the mean 24h IOP after each treatment. Secondary endpoints included the comparisons of IOP at each timepoint of the 24h curve and the comparison of BP, HR, ocular perfusion pressure and tolerability.Mean untreated 24h IOP was 20.3 mmHg (95%CI 19.0 to 21.6). Mean 24h IOP was significantly lower after 8 weeks of treatment with bimatoprost 0.01% than after 8 weeks of treatment with timolol 0.5% bid (15.7 vs 16.8 mmHg, p = 0.0003). Mean IOP during the day hours was significantly reduced from baseline by both drugs while mean IOP during the night hours was reduced by -2.3 mmHg (p = 0.0002) by bimatoprost 0.01% plus placebo and by -1.1 mmHg by timolol 0.5% bid (p = 0.06). Timolol 0.5% significantly reduced the mean 24h systolic BP from baseline, the diastolic BP during the day hours, the HR during the night hours, and the mean 24h systolic ocular perfusion pressure.Both Bimatoprost 0.01% and Timolol 0.5% are effective in reducing the mean 24h IOP from an untreated baseline but Bimatoprost 0.01% is more effective than timolol 0.5% throughout the 24h. Timolol 0.5% effect on IOP is reduced during the night hours and is associated with reduced BP, HR and ocular perfusion pressure.EU Clinical Trial Register and EudraCT# 2010-024272-26.

Project description:PurposeTo determine the 24-hour effects of travoprost with sofZia on intraocular pressure (IOP) and ocular perfusion pressure as well as the endurance of IOP lowering after last dosing.DesignProspective, open-label study.MethodsForty subjects with open-angle glaucoma or ocular hypertension were admitted to our sleep laboratory for three 24-hour sessions monitoring IOP, blood pressure (BP), and heart rate. The first baseline session occurred after medication washout or immediately after enrollment for treatment-naïve patients. A second 24-hour monitoring session was performed after 4 weeks of once-nightly treatment of travoprost with sofZia. The medication was then discontinued and a third 24-hour session was completed 60-84 hours after the last dose taken. IOP measurements were taken using a pneumotonometer every 2 hours in the sitting position during the 16-hour diurnal period and in the supine position during the 8-hour nocturnal period. Ocular perfusion pressure was defined as 2/3[diastolic BP + 1/3(systolic BP - diastolic BP)] - IOP.ResultsTreatment with travoprost with sofZia significantly lowered mean diurnal and nocturnal IOP levels from baseline (diurnal 18.1 ± 3.9 to 15.3 ± 3.3 mm Hg; nocturnal 20.6 ± 3.6 to 19.4 ± 3.4 mm Hg, P < .01 for both). Once treatment was discontinued, mean IOP remained at levels significantly less than baseline during both the diurnal (16.6 ± 3.8 mm Hg) and nocturnal periods (19.4 ± 3.5 mm Hg). Mean baseline ocular perfusion pressure was significantly increased during the diurnal but not the nocturnal period (diurnal 73.7 ± 11.4 to 76.5 ± 10.3 mm Hg, P = .01; nocturnal 64.4 ± 12.6 to 64.2 ± 11.1 mm Hg, P = .67).ConclusionTravoprost with sofZia significantly lowers IOP throughout the diurnal and nocturnal periods, and increases ocular perfusion pressure in the diurnal, but not the nocturnal, period in open-angle glaucoma and ocular hypertension. The treatment effect on IOP endures for at least 84 hours after the last dose.

Dataset Information

Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure.

Publications

Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure.

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