Association of Oxymetazoline Hydrochloride, 0.1%, Solution Administration With Visual Field in Acquired Ptosis

Slonim, Charles B.; Foster, Shane; Jaros, Mark; Kannarr, Shane; Korenfeld, Michael S; Smyth-Medina, Robert; Wirta, David

doi:10.1001/jamaophthalmol.2020.3812

Cited by 24 publications

(72 citation statements)

References 38 publications

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“…The design of, as well as primary and secondary efficacy and safety data from, the two double-masked, placebo controlled, multicenter phase 3 studies (Study RVL-1201-201 [NCT02436759]; Study RVL-1201-202 [NCT03565887]) included in this analysis has been previously described. 24 Both studies were conducted in accordance with the principles of the Declaration of Helsinki. The studies enrolled subjects at 16 and 27 sites, respectively, in the United States.…”

Section: Methodsmentioning

confidence: 99%

“…The treatment protocol, schedule of study visits, and assessments for both studies have been previously described. 24 Briefly, visits were carried out for screening and on treatment days 1, 14, and 42 (or upon early termination). The current analysis extends previously reported results by evaluating the change in MRD-1 (the distance between the center of the pupillary light reflex and the upper eyelid margin with the eye in primary gaze) at additional time points over multiple days, with a focus on onset of action on treatment days 1, 14, and 42.…”

Section: Methodsmentioning

confidence: 99%

“…MRD-1 was also evaluated at these time points in Study RVL-1201-202, as well as at additional times more closely following drop instillation (5 minutes and 15 minutes post-instillation on treatment days 1, 14, and 42). As reported by Slonim et al, 24 MRD-1 measurements in both studies were made from digital photographs taken at the defined time points, with significant care to ensure consistent ambient lighting for photography at all sites. Subjects were asked to relax their facial muscles, and the photograph framed the subject’s face from mid-forehead to the tip of the nose vertically and from ear-to-ear horizontally.…”

Section: Methodsmentioning

confidence: 99%

“…Determination of sample size and detailed statistical methods used in analyzing pooled change from baseline data for the two randomized studies included in this report have been previously described. 24 Analyses were conducted using each study’s full analysis population (all subjects receiving ≥1 dose of treatment). Descriptive statistics for observed values and changes from baseline for efficacy endpoints were tabulated by visit and treatment group, and differences between treatment groups compared using analysis of covariance (ANCOVA) model with treatment and study as fixed factors and baseline score as a covariate.…”

Section: Methodsmentioning

confidence: 99%

“…In these trials, administration of oxymetazoline 0.1% once daily in both eyes resulted in significant improvements on the primary and secondary endpoints: superior visual field deficits and upper eyelid elevation on treatment days 1 (6 hours post-instillation) and 14 (2 hours post-instillation). 24 The objective of this analysis was to further characterize the effect of oxymetazoline 0.1% on upper eyelid elevation in these studies, with a focus on the onset of effect after administration, as well as maintenance of the effect over 42 days of use.…”

Section: Introductionmentioning

confidence: 99%

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Rapid and Sustained Eyelid Elevation in Acquired Blepharoptosis with Oxymetazoline 0.1%: Randomized Phase 3 Trial Results

Bacharach¹,

Wirta²,

Smyth-Medina³

et al. 2021

OPTH

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Purpose Oxymetazoline 0.1% is a novel ophthalmic agent for the treatment of acquired blepharoptosis in adults that has been shown to improve upper eyelid elevation and superior visual field deficits. This analysis characterized the rapid onset of upper eyelid elevation with once-daily oxymetazoline 0.1% and durability of this effect over 42 days. Materials and Methods Pooling data from two prospective, randomized, placebo-controlled, phase 3 studies, change in marginal reflex distance 1 (MRD-1) was evaluated at a range of post-instillation time points on treatment days 1, 14, and 42. Onset of effect was assessed beginning at 5 minutes post-administration (one study) and through 6 hours at the first two visits (both studies). Overall, 203 subjects received oxymetazoline 0.1% and 101 received vehicle. Results Oxymetazoline 0.1% demonstrated a rapid onset of action on all days evaluated. Mean changes from baseline 5 and 15 minutes post-oxymetazoline 0.1% instillation on day 1 were 0.59 ± 0.72 mm and 0.93 ± 0.81 mm, respectively (vs 0.20 ± 0.57 mm and 0.32 ± 0.64 mm with vehicle; both p<0.001). On day 14, mean changes from baseline 5 and 15 minutes post-oxymetazoline 0.1% instillation were 0.77 ± 0.85 mm and 1.11 ± 0.92 mm, respectively (vs 0.42 ± 0.78 mm and 0.41 ± 0.83 mm with vehicle; both p<0.05). This effect was also observed immediately post-instillation on day 42, where mean increases 5 and 15 minutes post-oxymetazoline 0.1% instillation were 0.86 ± 0.85 mm and 1.04 ± 0.91 mm, respectively (vs 0.42 ± 0.80 mm and 0.47 ± 0.93 mm with vehicle; both p<0.005). Significant improvements vs vehicle (p<0.001) were also observed at 2–6 hours on days 1 and 14. At all time points, the proportion of subjects showing a positive response to treatment (>0% MRD-1 increase) was >15% greater in the oxymetazoline 0.1% group (range 16.6–36.1% more responders vs vehicle), with the largest differences observed 2 and 6 hours post-instillation. Conclusion Oxymetazoline 0.1% provided rapid and sustained upper eyelid elevation. Together with data demonstrating superior visual field improvement and a favorable safety profile, this analysis supports oxymetazoline 0.1% as an effective non-surgical treatment for acquired ptosis.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Rapid and Sustained Eyelid Elevation in Acquired Blepharoptosis with Oxymetazoline 0.1%: Randomized Phase 3 Trial Results

Bacharach¹,

Wirta²,

Smyth-Medina³

et al. 2021

OPTH

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Oxymetazoline for Ptosis

Bradley

2020

JAMA Ophthalmol

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Oxymetazoline (Afrin) nasal spray was approved by the US Food and Drug Administration (FDA) more than 50 years ago for the treatment of nasal congestion. In July 2020, the FDA approved a new formulation in which a higher concentration of oxymetazoline has been incorporated into eyedrops. These eyedrops allow oxymetazoline to elevate the eyelid by activating α-adrenergic receptors in the Muller muscle. In this issue of JAMA Ophthalmology, Slonim et al 1 report the results of 2 industry-sponsored randomized placebo-controlled masked trials that assess the efficacy of oxymetazoline, 0.1%, eyedrops for ptosis.Repurposing an old drug has its appeal. An old drug comes with a known adverse effect profile and an established manufacturing base. However, proving that an old drug can safely and effectively take on a new role may not be easy. Consider the experience with hydroxychloroquine. Long a mainstay in the treatment of malaria, lupus erythematosus, and rheumatoid arthritis, hydroxychloroquine has been associated in observational data with improved survival among patients with coronavirus disease 2019. 2 However, despite some initial promising findings, the drug has faced considerable controversy, and the FDA revoked its emergency use authorization. Randomized clinical trials have not necessarily shown benefit. 3 Finding a new purpose for an old drug may be even more daunting if the drug is perceived as a potential threat to established surgical practice. Such a drug could conceivably help patients delay or even avoid the potential discomfort, cost, and morbidity of surgery. However, in addition to appropriate scientific skepticism, use of the drug may be met with resistance from surgeons whose livelihood may be harmed financially by the drug.In their studies of oxymetazoline hydrogen chloride (HCl), 0.1%, Slonim et al 1 randomized a total of 304 patients with acquired ptosis to topical oxymetazoline HCl, 0.1%, vs vehicle in 2 trials. These are industry-sponsored trials for which the authors report that RevitaLid Inc played a role in the conduct, analysis, and reporting of the studies. All but 1 participant was an adult, and all participants had clinically relevant involutional ptosis defined by superior visual field loss and reduced eyelid height. Response to therapy was evaluated at 1 day and 14 days of treatment, and safety was evaluated over 42 days of follow-up. Using Leicester Humphrey Visual Field (HVF) static perimetry as the primary outcome, the authors showed a change in the oxymetazoline treatment arm of 4 to 5 points of superior visual field more than the change in the vehicle arm. The secondary outcome, change in upper eyelid height, increased by less than 0.5 mm in the treatment arm compared with the vehicle arm on day 1 and by 0.67 mm compared with vehicle on day 14. Oxymetazoline HCl, 0.1%, was generally well tolerated, with no change in visual acuity or in-

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Progressively worsening ptosis in a woman: A case report

Zhao,

Ren,

Yang

et al. 2024

Clinical Case Reports

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Key Clinical MessageFiller injections into the upper eyelid may cause levator aponeurosis fibrosis and ptosis. This risk must be considered. When ptosis appears, treatment might be difficult. Understanding the upper eyelid anatomy and procedures is essential to prevent eyelid damage.AbstractPtosis is a prevalent condition in cosmetic surgery that occurs due to malfunction of the levator palpebrae superioris or insufficient Müller muscle action. It is characterized by the upper eyelid edge appearing lower than usual when seen at eye level. Ptosis may be categorized into congenital and acquired forms. The primary cause of congenital ptosis is attributed to abnormalities of the levator palpebrae superioris muscle or the motor nerve innervation that controls it. The condition arises from atypical development and malfunction of the oculomotor system. Acquired ptosis may be classified into many categories including traumatic, neurogenic, myogenic, senile, mechanical, and fake ptosis. Currently, there is little documentation of ptosis resulting from the degeneration of the aponeurosis of the muscle in the upper eyelid. We received a case of ptosis caused by fibrosis of the levator palpebrae superioris aponeurotic membrane. We used the technique of levator palpebrae superioris great advancement. The levator palpebrae superioris—Müller muscle was folded to create a stable composite construction via the levator palpebrae superioris high progress.

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Association of Oxymetazoline Hydrochloride, 0.1%, Solution Administration With Visual Field in Acquired Ptosis

Cited by 24 publications

References 38 publications

Rapid and Sustained Eyelid Elevation in Acquired Blepharoptosis with Oxymetazoline 0.1%: Randomized Phase 3 Trial Results

Rapid and Sustained Eyelid Elevation in Acquired Blepharoptosis with Oxymetazoline 0.1%: Randomized Phase 3 Trial Results

Oxymetazoline for Ptosis

Progressively worsening ptosis in a woman: A case report

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