Comparison of Efficacy of Difluprednate 0.05% and Loteprednol Gel 0.5% After Cataract Surgery

Abessi, Bryan; Brooksby, Lauren; Schultze, R.

doi:10.1097/icl.0000000000000407

Cited by 9 publications

(12 citation statements)

References 18 publications

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“…Phacoemulsification as a cataract surgery technique was proposed over 40 years ago, and advances in surgical approaches and equipment have increased its safety and efficiency. 13,18,19 However, post-operative ocular inflammation remains as a cause of visual impairment and pain. The degree of postoperative inflammation following cataract surgery is related to several surgery-dependent factors such as technique used, intraocular lens type, and to patient-dependent factors such as degree of iris pigmentation, and history of inflammatory disease, among others.…”

Section: Discussionmentioning

confidence: 99%

“…Difluprednate is an ophthalmic steroid with high glucocorticoid receptorbinding affinity and high tissue penetration, therefore it is considered more potent than other topically applied steroids. [12][13][14] Ocular inflammation is assessable through clinical signs such as anterior chamber (AC) cellularity and flare, corneal edema, elevated IOP, and cystoid macular edema (CME). Symptoms such as ocular pain, photophobia, tearing, blurry vision, and itching may also be associated with ocular inflammation.…”

Section: Introductionmentioning

confidence: 99%

“…Symptoms such as ocular pain, photophobia, tearing, blurry vision, and itching may also be associated with ocular inflammation. 11,13,15 Steroids have been proven to cause IOP elevation; however, it has been reported that difluprednate administered 2 times daily for 30 days, resulted in no significant differences in the mean or IOP elevation percentages compared to prednisolone acetate after cataract surgery. These results can be attributed to a low-frequency dosing during a short period of steroid use.…”

Section: Introductionmentioning

confidence: 99%

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<p>Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial</p>

Palacio-Pastrana¹,

Chávez-Mondragón²,

Soto-Gómez³

et al. 2020

OPTH

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Background: The purpose of this study was to compare the efficacy and safety of difluprednate 0.05% (PRO-145) versus prednisolone acetate 1% (Prednefrin ® SF), for management of postoperative inflammation and pain, after cataract surgery. Methods: This was a Phase III, multicenter, prospective, double-blind, clinical trial. Intentto-treat population included 178 post-phacoemulsification patients that were assigned to receive either PRO-145, or prednisolone. One day after unilateral eye surgery, patients instilled a drop 4 times a day for 14 days (then tapering the dose downward for 14 days). The primary efficacy endpoints were anterior chamber (AC) cell grade and flare. Other parameters measured included: retinal central thickness (measured via OCT), conjunctival hyperemia, edema, pain and photophobia. Tolerability and safety were assessed through burning, itching, foreign body sensation, visual acuity (VA), intraocular pressure (IOP) and incidence of adverse events (AE). Results: A total of 171 subjects were randomized (1:1) and completed the study. Compared to day 1, there was a significant improvement in the AC cell count and flare in both groups by the final visit (80.2% vs 88.4%, p=1.000). Conjunctival hyperemia improved in a similar fashion (81.2% vs 79%, p=0.234) in both PRO-145 and prednisolone groups, without differences between them. This was also observed for edema (82.4% vs 82.5%, p=0.246), pain (15.3% vs 7%, p=0.497) and photophobia (16.4% vs 15.1%, p=0.246), respectively. There was no significant difference between treatments for any tolerability parameter studied. Finally, at the 4-week postoperative visit, there were no significant differences between treatments for VA, IOP and AE results (p-values; 0.095, 0.053 and 0.099, respectively). Conclusion: The results of this study suggest that PRO-145 is as effective and safe as prednisolone acetate in treating postoperative inflammation and pain in patients undergoing phacoemulsification. The study was registered at ClinicalTrials.gov as NCT03693989.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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<p>Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial</p>

Palacio-Pastrana¹,

Chávez-Mondragón²,

Soto-Gómez³

et al. 2020

OPTH

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“…LE gel 0.5% (n = 30) was compared with difluprednate 0.05% (n = 30) for decreasing inflammation and improving vision recovery after phacoemulsification cataract surgery in an investigator-masked study [63]. All patients instilled assigned medication QID 3 days preoperatively and one week postoperatively, then BID for one week.…”

Section: Le Gelmentioning

confidence: 99%

“…The combination of efficacy and safety often renders a 'smart steroid' designation, while efficacy purported to be less than other steroids such as difluprednate somewhat inaccurately recalls the 'soft steroid' moniker, a label originally coined to reflect better safety. In reality, as demonstrated in both tightly controlled animal model experiments and human trials, LE performs with admirable potency for a variety of indications compared to other topical steroids [20,33,45,[47][48][49][50]52,[62][63][64], the nonsteroidal anti-inflammatory ketorolac [44], and tCSA [36,65]. However, the rapid metabolism responsible for the improved safety of LE could result in slightly lower efficacy relative to other corticosteroids in cases of particularly severe, acute inflammation as suggested by one of two studies in acute anterior uveitis [33].…”

Section: Expert Opinionmentioning

confidence: 99%

Loteprednol etabonate for inflammatory conditions of the anterior segment of the eye: twenty years of clinical experience with a retrometabolically designed corticosteroid

Comstock¹,

Sheppard

2018

Expert Opinion on Pharmacotherapy

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Topical corticosteroids are an important pharmacotherapy for the management of various inflammatory conditions affecting the anterior segment of the eye. However, medications in this class are associated with well-known risks including increased intraocular pressure (IOP) and development of cataracts. The topical corticosteroid loteprednol etabonate (LE) was developed with the specific intention of minimizing these side effects. Areas covered: The focus of this review is to examine published efficacy and safety data for LE, a drug engineered to undergo rapid metabolism to inactive metabolites with the goal of improved safety. Two decades of clinical research focused on LE formulations are reviewed, including the use of LE in combination with tobramycin. The cumulative body of experience affirms the concept that the molecular design of LE confers certain safety benefits without compromising the desired anti-inflammatory efficacy of a topical corticosteroid. Expert opinion: Loteprednol etabonate is a mainstay for topical therapy of a wide variety of commonplace and niche conditions of the ocular surface and the anterior segment, including in the healing post-operative patient. Its versatility and safety allow eye care providers to recommend both acute induction as well as chronic maintenance therapy with appropriate follow-up.

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Rheological Properties, Dissolution Kinetics, and Ocular Pharmacokinetics of Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38%

Cavet¹,

Glogowski²,

Lowe

et al. 2019

Journal of Ocular Pharmacology and Therapeutics

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Purpose: To evaluate rheological properties, in vitro dissolution, and in vivo ocular pharmacokinetics of loteprednol etabonate (LE) (submicron) ophthalmic gel 0.38%. Methods: The viscosity of the LE gel 0.38% formulation was measured with a controlled stress rheometer. Dissolution kinetics were evaluated in a fixed-volume and flow-through assay. Rabbits received a single instillation of LE (submicron) gel 0.38% (both eyes), and concentrations of LE in ocular tissues were determined through 24 h by liquid chromatography with tandem mass spectrometry. Where indicated, comparators included micronized LE gel 0.38%, 0.5% (Lotemax ® gel), and 0.75%. Results: LE (submicron) gel 0.38% exhibited shear-thinning characteristics similar to LE gel 0.5% with nearly identical yield stress. LE (submicron) gel 0.38% released 2.6-fold more LE into the dissolution medium than micronized LE gel 0.5% over 30 s in the fixed-volume dissolution assay, and submicron LE attained higher concentrations of dissolved LE than micronized LE gel 0.38% in the flow-through dissolution assay. In rabbits, the maximal concentration and area-under-the-curve over 24 h for LE in aqueous humor were 2.5- and 1.8-fold higher, respectively, for LE (submicron) gel 0.38% versus micronized LE gel 0.5% (both P < 0.001). Pharmacokinetic parameters were similar for most other tissues. Conclusions: LE (submicron) gel 0.38% demonstrated similar rheological properties to micronized LE gel 0.5% but faster dissolution, thus providing similar or higher LE concentrations in the aqueous humor, cornea, and iris-ciliary body after ocular dosing in rabbits despite a lowered concentration of drug in the formulation.

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Comparison of Efficacy of Difluprednate 0.05% and Loteprednol Gel 0.5% After Cataract Surgery

Abstract: The anti-inflammatory effect, visual recovery, and IOP of patients using topical difluprednate or loteprednol gel after cataract surgery are equivalent. There may be an additional short-term benefit of loteprednol gel in protecting the ocular surface after cataract surgery.

Cited by 9 publications

References 18 publications

<p>Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial</p>

<p>Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial</p>

Loteprednol etabonate for inflammatory conditions of the anterior segment of the eye: twenty years of clinical experience with a retrometabolically designed corticosteroid

Rheological Properties, Dissolution Kinetics, and Ocular Pharmacokinetics of Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38%

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