Dataset Information

The diurnal and nocturnal effect of travoprost with sofZia on intraocular pressure and ocular perfusion pressure.

ABSTRACT:

Purpose

To 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.

Design

Prospective, open-label study.

Methods

Forty 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.

Results

Treatment 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).

Conclusion

Travoprost 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.

SUBMITTER: Seibold LK

PROVIDER: S-EPMC3894832 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The diurnal and nocturnal effect of travoprost with sofZia on intraocular pressure and ocular perfusion pressure.

Seibold Leonard K LK Kahook Malik Y MY

American journal of ophthalmology 20131030 1

<h4>Purpose</h4>To 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.<h4>Design</h4>Prospective, open-label study.<h4>Methods</h4>Forty 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 ...[more]

PMID: 24182742

Similar Datasets

Project description:Prostaglandin analogs reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; however, these medications may affect the ocular surface and elicit ocular discomfort when preserved with benzalkonium chloride (BAK).This was an open-label, single-arm study conducted in Latin America from February 2012 to May 2013. Patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost 0.005 % were transitioned to receive once-daily BAK-free travoprost 0.004 % containing polyquaternium-1 (Travatan® preserved with POLYQUAD® [PQ], Alcon Laboratories, Inc; Fort Worth, TX) for 12 weeks. Mean change in IOP from baseline (primary efficacy endpoint) and the percentage of patients who achieved a target IOP of ?18 mmHg were evaluated at all on-therapy visits. Ocular hyperemia, patient preference, and self-projected adherence were assessed at week 12. Adverse events (AEs) were monitored throughout the study.All enrolled patients were included in the analysis (n?=?191); the majority of patients (90.6 %, n?=?173/191) completed the study. Mean (SD) patient age was 67.5 (11.3) years, and mean baseline IOP was 14.8 mmHg. Mean IOP was reduced by 0.94 mmHg at week 6 and by 1.09 mmHg at week 12 (P?<?0.001 for both). A greater percentage of patients achieved a target IOP of ?18 mmHg at week 6 (93.1 %; n?=?163/175) and week 12 (93.3 %; n?=?166/178) compared with baseline (89.5 %; n?=?171/191). There was a 10.5 % increase in the percentage of patients with "none/trace" amounts of hyperemia. Most patients preferred the study medication (81.5 %; n?=?141/173) and were confident that they would adhere to their preferred medication (90.8 %; n?=?157/173). No serious AEs were reported, and eye irritation (3.7 %; n?=?7/191) was the most common treatment-related AE.Transitioning from BAK-containing latanoprost 0.005 % to BAK-free travoprost 0.004 % preserved with PQ reduced IOP in patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost. BAK-free travoprost 0.004 % is a viable alternative for patients who require switching their IOP-lowering medications because of tolerability issues.ClinicalTrials.gov identifier, NCT01510145.

Project description:BackgroundMedications 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.MethodsThis 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.ResultsOne 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.ConclusionLate-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.Trial registrationClinicalTrials.gov identifier, NCT01464424; registered November 1, 2011.

Project description:IntroductionThe efficacy of lowering intraocular pressure (IOP) and safety of switching to travoprost/timolol fixed combination ophthalmic solution (Duotrav(®), Alcon Laboratories, Inc., Fort Worth, TX, USA) in patients with primary open-angle glaucoma, normal tension glaucoma or ocular hypertension undergoing prostaglandin analog (PGA) monotherapy was investigated.MethodsPatients treated with travoprost, latanoprost, tafluprost, or bimatoprost for ≥3 months and requiring additional medication were switched to Duotrav without washout. Baseline IOP was calculated from measurements at two visits during PGA monotherapy. IOP reductions at 4, 8, and 12 weeks after switching to Duotrav and adverse events were assessed.ResultsOf 162 patients enrolled, 157 patients (96.9%) with ≥4 weeks of follow-up after switching to Duotrav were analyzed. The mean IOP decreased significantly (baseline = 16.3 ± 3.1 mmHg; 4 weeks = 14.6 ± 3.1 mmHg, 8 weeks = 14.7 ± 3.3 mmHg, 12 weeks = 14.6 ± 3.2 mmHg; all P < 0.0001). When study eyes were divided into three groups according to baseline IOP (≥19 mmHg: 33 eyes, 21.0%; ≥15 to <19 mmHg: 78 eyes, 49.7%; <15 mmHg: 46 eyes, 29.3%), all groups showed significant IOP reductions (P = 0.0324 ~ P < 0.0001) after switching to Duotrav. Twenty-seven of 166 patients (16.3%) in the safety analysis experienced adverse events and 26/166 patients (15.7%) experienced adverse events, for which a relationship to Duotrav could not be ruled out. Adverse events in five patients led to treatment discontinuation (eye pruritus; eye irritation; increased blood pressure and rash; increased blurred vision; deepening of the eyelid sulcus and blepharoptosis). Twelve weeks after treatment switching, eyelash changes, blepharal pigmentation and deepening of the eyelid sulcus occurred in 42 (26.8%), 29 (18.5%), and 13 (8.3%) cases, respectively, among 157 patients with follow-up. There was no significant worsening from baseline for superficial punctate keratopathy (SPK) or conjunctival hyperemia after switching (SPK score: baseline = 0.58 ± 1.31; 12 weeks = 0.92 ± 1.76, P = 0.1819; conjunctival hyperemia score: baseline = 0.41 ± 0.64; 12 weeks = 0.49 ± 0.63, P = 0.3774).ConclusionOur findings confirm that switching to Duotrav(®) in PGA monotherapy patients shows IOP-lowering effect with minimal safety concerns.FundingJapan Association of Health Service and Alcon Japan. Ltd.Trial registrationUMIN Clinical Trials Registry identifier, UMIN000007028.

Dataset Information

The diurnal and nocturnal effect of travoprost with sofZia on intraocular pressure and ocular perfusion pressure.

Purpose

Design

Methods

Results

Conclusion

Publications

The diurnal and nocturnal effect of travoprost with sofZia on intraocular pressure and ocular perfusion pressure.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets