A double-masked randomized comparison of the efficacy and safety of unoprostone with timolol and betaxolol in patients with primary open-angle glaucoma including pseudoexfoliation glaucoma or ocular hypertension. 6 month data

Nordmann, Jean‐Philippe; Mertz, Beat P.; Yannoulis, N.C.; Schwenninger, Christine; Kapik, Barry; Shams, Naveed

doi:10.1016/s0002-9394(01)01337-x

Cited by 65 publications

(7 citation statements)

References 6 publications

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“…In this study there were no clinically relevant changes in pulmonary function and cardiovascular parameters (blood pressure and heart rate), consistent with other trials conducted with unoprostone [19, 30, 31, 32]. …”

Section: Discussionsupporting

confidence: 92%

“…The mild burning and stinging sensations that occurred after use of unoprostone 0.15% were transient and have previously been reported [19]. …”

Section: Discussionmentioning

confidence: 82%

“…Two pharmacology studies were conducted to determine the dose and dosing regimen [17, 18]. The IOP-lowering efficacy of unoprostone 0.15% has been confirmed both in monotherapy [19]and in adjunctive therapy to timolol [20]. The present study evaluated the new dose formulation (unoprostone 0.15%) in Caucasian patients with stable mild to moderate reversible obstructive airway disease (bronchial asthma).…”

Section: Introductionmentioning

confidence: 99%

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Safety of Unoprostone Isopropyl 0.15% Ophthalmic Solution in Patients with Mild to Moderate Asthma

Gunawardena

Crame²,

Mertz³

et al. 2003

Ophthalmologica

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Purpose: To assess the safety of unoprostone isopropyl 0.15% ophthalmic solution (UIOS) in patients with mild to moderate asthma. Methods: Randomized, double-masked, two-period crossover, placebo-controlled study comparing unoprostone 0.15% with vehicle-placebo. Pulmonary function tests conducted at baseline and during the 4-hour postdose observation period included forced expiratory volume in 1 s, forced vital capacity, peak expiratory flow rate, and bronchodilator response after 200 µg inhaled salbutamol. Results: There were no significant changes in pulmonary function up to 4 h postdose after treatment with 1 drop unoprostone 0.15% in each eye. Conclusion: Unoprostone 0.15% was safe for use in patients with mild to moderate asthma, without affecting the response to bronchodilator therapy.

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Section: Discussionsupporting

confidence: 92%

“…The mild burning and stinging sensations that occurred after use of unoprostone 0.15% were transient and have previously been reported [19]. …”

Section: Discussionmentioning

confidence: 82%

Section: Introductionmentioning

confidence: 99%

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Safety of Unoprostone Isopropyl 0.15% Ophthalmic Solution in Patients with Mild to Moderate Asthma

Gunawardena

Crame²,

Mertz³

et al. 2003

Ophthalmologica

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“…In the comparative trial of unoprostone, timolol, and betaxolol by Nordmann et al discussed in the Unoprostone as monotherapy section, adverse events were similar for the three treatment groups except for burning/stinging, burning/stinging upon drug instillation, and ocular itching, which were more common with unoprostone than with timolol but less common than with betaxolol 60. Hyperemia was also more common with unoprostone (10.8%) than with timolol (3.6%) or betaxolol (5.0%).…”

Section: Safety and Tolerabilitymentioning

confidence: 94%

“…Following one month of therapy, both agents produced significant reductions in IOP and increases in pulsatile ocular blood flow, although the changes seen with latanoprost were nearly two-fold greater than those seen with unoprostone, which was statistically significant. Although some studies have found equivalent IOP reduction between timolol and unoprostone,48–50 Nordmann et al in a 24-month multicenter, double-masked, randomized trial of 556 patients with glaucoma or ocular hypertension who received either twice-daily unoprostone, betaxolol, or timolol for 6 months, found similar mean diurnal IOP-lowering efficacy between betaxolol and unoprostone monotherapy 60. Both groups achieved an IOP reduction of 3–4 mmHg, or 18%–20%, from baseline.…”

Section: Efficacymentioning

confidence: 98%

An evidence-based review of unoprostone isopropyl ophthalmic solution 0.15% for glaucoma: place in therapy

Fung¹,

Whitson

2014

OPTH

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Glaucoma is a progressive, neurodegenerative optic nerve disease that can cause significant visual morbidity and affects over 60 million people worldwide. The only known modifiable risk factor for glaucoma at this time is elevated intraocular pressure (IOP), which may be treated with medications, laser therapy, and/or incisional surgery. Topical ocular medications are commonly used as first-line therapy for glaucoma, although side effects may limit their use. Unoprostone is a novel 22-carbon ocular hypotensive agent that may be advantageous in treating some patients with open angle glaucoma or ocular hypertension. Unlike the 20-carbon prostanoids, such as latanoprost, that lower IOP primarily through an increase in uveoscleral outflow, unoprostone may lower IOP through increased aqueous outflow via the conventional trabecular meshwork pathway. Although not as efficacious as other prostanoids, unoprostone is effective for IOP reduction both as monotherapy and adjunctive therapy with timolol. Unoprostone has decreased affinity for the prostaglandin F2α receptor, which may explain its well tolerated ocular and systemic side effect profile compared with other prostanoids.

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Increase in Outflow Facility With Unoprostone Treatment in Ocular HypertensivePatients

2004

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To determine the mechanism by which 0.15% unoprostone isopropyl reduces intraocular pressure (IOP) by studying 33 patients with ocular hypertension or primary open-angle glaucoma.Methods: At baseline, IOP was determined by pneumatonometry, aqueous flow and outflow facility by fluorophotometry, episcleral venous pressure by venomanometry, and uveoscleral outflow by mathematical calculation. Unoprostone was administered to one eye and placebo to the fellow eye of each patient twice daily in a randomized masked fashion. In patients who demonstrated an IOP reduction of 3 mm Hg or more in either eye on day 5±1 (n = 29), determinations were repeated on that day and on day 28 ± 2. Treated eyes were compared with control eyes, and treatment days were compared with baseline by paired t tests.Results: Compared with baseline, unoprostone significantly (PϽ.001) reduced IOP by a mean±SEM of 5.6±0.4 mm Hg and 4.8±0.6 mm Hg on days 5 and 28, respectively. The change from baseline with unoprostone was significantly (PϽ.001) greater than with placebo by 2.8±0.4 mm Hg on day 5 and by 3.2±0.5 mm Hg on day 28. Compared with baseline, unoprostone significantly (PՅ.001) increased outflow facility by 0.05±0.01 and 0.08±0.02 µL•min −1 •mm Hg −1 on days 5 and 28, respectively. The baseline-adjusted between-treatment differences were significant (PՅ.04) on day 28 (0.06±0.02 µL•min −1 •mm Hg −1 ). Other measures were not different from placebo. Conclusion:In responsive patients, unoprostone decreased IOP by increasing outflow facility.

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A double-masked randomized comparison of the efficacy and safety of unoprostone with timolol and betaxolol in patients with primary open-angle glaucoma including pseudoexfoliation glaucoma or ocular hypertension. 6 month data

Cited by 65 publications

References 6 publications

Safety of Unoprostone Isopropyl 0.15% Ophthalmic Solution in Patients with Mild to Moderate Asthma

Safety of Unoprostone Isopropyl 0.15% Ophthalmic Solution in Patients with Mild to Moderate Asthma

An evidence-based review of unoprostone isopropyl ophthalmic solution 0.15% for glaucoma: place in therapy

Increase in Outflow Facility With Unoprostone Treatment in Ocular HypertensivePatients

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