A Prospective, Open-label Study to Compare the Efficacy and the Safety of Topical Loteprednol Etabonate and Topical Flurbiprofen Sodium in Patients with Post-Operative Inflammation after Cataract Extraction

Bannale, Sheshidhar; Pundarikaksha, H P; Sowbhagya, H. N.

doi:10.7860/jcdr/2012/4759.2543

Cited by 7 publications

(4 citation statements)

References 5 publications

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“…Two prospective studies evaluated the comparative efficacy and safety of LE ophthalmic suspension 0.5% and topical nonsteroidal anti-inflammatory drugs (NSAIDs) in reducing inflammation after uncomplicated cataract surgery [ 39 , 40 ]. In an open-label study, Bannale et al [ 39 ] showed similar tolerability and safety profiles of LE 0.5% and flurbiprofen sodium 0.03% administered postoperatively four times daily for 4 weeks, with no reports of clinically significant IOP elevation in patients receiving either treatment ( n = 20). Holzer et al [ 40 ] compared the safety and efficacy of LE with those of ketorolac tromethamine 0.5% in a randomized double-masked study of 60 patients undergoing cataract surgery.…”

Section: Le Suspensions: Iop Data From More Recent Studiesmentioning

confidence: 99%

Impact of the Topical Ophthalmic Corticosteroid Loteprednol Etabonate on Intraocular Pressure

Sheppard

Comstock²,

Cavet³

2016

Adv Ther

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Corticosteroids are a mainstay therapeutic option for the treatment of ocular inflammation. However, safety remains a concern for clinicians, particularly with long-term use. Though highly effective at suppressing inflammatory and allergic responses, topical ophthalmic corticosteroids carry an inherent risk of side effects, including elevated intraocular pressure (IOP), a risk factor for the development of glaucoma. The corticosteroid loteprednol etabonate (LE) contains an ester rather than a ketone at the C-20 position, minimizing the potential for side effects, including IOP elevation. In early pivotal clinical trials of LE ophthalmic suspension for conjunctivitis (allergic, giant papillary), anterior uveitis, and post-operative inflammation, LE had minimal impact on IOP over short-term (<28 days) and long-term (≥28 days) use. Since then, new LE formulations—including a gel, an ointment, and a suspension of LE in combination with tobramycin—have become commercially available. Multiple studies evaluating the safety and efficacy of LE for inflammatory conditions have been reported, including those requiring longer-term treatment such as photorefractive keratectomy, corneal transplantation, and dry eye disease. We review the available published data on the effect of LE on IOP and report on the cumulative incidence of clinically significant IOP elevations (≥10 mm Hg from baseline) with short-term and long-term LE use. In all studies, LE consistently demonstrated a low propensity to elevate IOP, regardless of formulation, dosage regimen, or treatment duration, including in known steroid responders. The cumulative proportion of patients exhibiting clinically significant IOP increases was 0.8% (14/1725 subjects) in studies evaluating short-term LE treatment and 1.5% (21/1386 subjects) in long-term studies. Furthermore, use of LE was associated with significantly lower rates of IOP elevation ≥10 mm Hg as compared to prednisolone acetate or dexamethasone (when used in combination with tobramycin). The cumulative data to date substantiates a favorable IOP-safety profile for LE with both short-term and long-term use.

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Section: Le Suspensions: Iop Data From More Recent Studiesmentioning

confidence: 99%

Impact of the Topical Ophthalmic Corticosteroid Loteprednol Etabonate on Intraocular Pressure

Sheppard

Comstock²,

Cavet³

2016

Adv Ther

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“…Additional mechanisms like suppressing the leukocyte motility and chemotaxis, inhibiting the inflammatory cytokines and the free radical scavenging activity, may also contribute to their antiinflammatory action. 8 Nepafenac, a newer topical NSAID, also showed similar favourable effects. It is a prodrug.…”

Section: Introductionmentioning

confidence: 76%

A comparative study on efficacy of nepafenac and flurbiprofen in maintenance of intraoperative mydriasis during cataract surgery: an open label randomized controlled trial

Prakash

Bhandare

Satyanarayana

et al. 2018

Int J Basic Clin Pharmacol

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Background: Surgery on the ocular tissue brings about activation of phospholipase A3 thereby releasing prostaglandins and leukotrienes. Prostaglandins bring about meiosis during surgery, changes in IOP, conjunctival hyperaemia. Newer topical NSAID’s Nepafenac and Flurbiprofen are potent inhibitors of the cyclooxygenase enzyme thereby inhibiting the biosynthesis of prostaglandins. Objective of this study was to compare the efficacy of preoperative use of topical Nepafenac (0.1%) and Flurbiprofen (0.03%) in maintenance of intraoperative mydriasis during cataract surgery.Methods: A randomised, comparative study was performed on 104 patients, 52 were allocated in each group and were given either of the topical NSAID’s Nepafenac or Flurbiprofen prior to cataract surgery. Pupillary diameter was measured at the beginning and at the end of the surgery and the values were compared between the groups. Mean and standard deviation was calculated and between two groups comparison was done using students t-test.Results: The mean pupillary diameter of the two groups were comparable at the beginning of surgery (p=0.34). The mean change in the pupillary diameter was 1.86±0.71mm in the Nepafenac group and 1.77±0.72mm in the Flurbiprofen group. There was no statistically significant difference among both the groups in maintenance of intraoperative mydriasis (p=0.47).Conclusions: Pre-operative use of Nepafenac and Flurbiprofen were equally effective in preventing meiosis during cataract surgery.

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“…3 Loteprednol is designed to be active locally at the site of administration and then rapidly metabolized to inactive components after eliciting its actions at the desired location, thereby subsequently minimizing the chance for adverse effects. 4 Hence, this prospective, interventional study was done to compare the efficacy and the tolerability of the topical steroid Loteprednol in the preoperative and postoperative period with the conventionally used topical NSAID Flurbiprofen in the preoperative period and loteprednol postoperatively in intraoperative mydriasis and postoperative outcomes.…”

Section: Introductionmentioning

confidence: 99%

A comparative study of the efficacy of preoperative loteprednol versus flurbiprofen in cataract surgery

Chand¹,

Chauhan²

2020

IJCEO

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To evaluate the efficacy and cost-effectiveness of preoperative loteprednol versus flurbiprofen, when combined with moxifloxacin in maintaining intraoperative mydriasis and reducing postoperative complications. Materials and Methods: 200 cataract patients were divided into 2 groups. Group 1 receiving preoperative Flurbiprofen(0.03%) with moxifloxacin(0.5%) and Group 2 receiving Loteprednol(0.5%) with moxifloxacin(0.5%), three times a day 24 hrs prior to cataract surgery,followed by postoperative loteprednol(0.5%) and moxifloxacin(0.5%) in both groups. Intraoperative mydriasis and post operative complications were analysed. Patients were followed up on day 1, 1 week, 3 weeks and 7 weeks. Parameters evaluated included inflammation, pain, corneal edema, anterior chamber reaction (including cells and flare), intraocular pressure, CME. Results: Intraoperative mydriasis obtained in both the groups was comparable with no significant difference. Postoperative visual outcome was also comparable but postoperative inflammation was slightly more in Group 1 (p <0.05). Pain was more in group 1 on first postoperative day which was not statistically significant but this difference did not persist during further follow ups. 3 patients in group 1 and 2 patients in Group 2 developed CME on the last follow up which was not statistically significant. The rest of the parameters were comparable in the 2 groups with a much better compliance in group 2. Conclusion: This hospital based study in western Rajasthan revealed Loteprednol to be equally potent as flurbiprofen in maintaining intraoperative mydriasis along with significant reduction of postoperative complications while maintaining cost effectiveness and compliance as a single eye drop was used before and after surgery, with no steroid related complications.

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A Prospective, Open-label Study to Compare the Efficacy and the Safety of Topical Loteprednol Etabonate and Topical Flurbiprofen Sodium in Patients with Post-Operative Inflammation after Cataract Extraction

Cited by 7 publications

References 5 publications

Impact of the Topical Ophthalmic Corticosteroid Loteprednol Etabonate on Intraocular Pressure

Impact of the Topical Ophthalmic Corticosteroid Loteprednol Etabonate on Intraocular Pressure

A comparative study on efficacy of nepafenac and flurbiprofen in maintenance of intraoperative mydriasis during cataract surgery: an open label randomized controlled trial

A comparative study of the efficacy of preoperative loteprednol versus flurbiprofen in cataract surgery

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