difluprednate and prednisolone-acetate

Topical steroids are the cornerstone in controlling the inflammation after cataract surgery. Prednisolone acetate and difluprednate are the two main products for this purpose. However, it is unclear which one should be used in terms of effectiveness and safety.. Systematic review and meta-analysis.. Medline via PubMed, Cochrane Central Register of Controlled Trials, Web of science and clinicaltrials.gov were searched through 10 January 2018, and updated on 20 July 2019, in addition to researching the references' lists of the relevant articles.. Randomised-controlled trials (RCTs) comparing difluprednate and prednisolone acetate regardless of the dosing regimen used.. Two independent authors assessed the included RCTs regarding the risk of bias using the Cochrane tool. Relevant data were extracted, and meta-analysis was conducted using a random-effects model. The Grading of Recommendations Assessment, Development, and Evaluation approach was used to appraise the evidence quality.. We included six RCTs with 883 patients: 441 received difluprednate and 442 received prednisolone acetate. The evidence quality was graded as moderate for corneal oedema and intraocular pressure and low for anterior chamber (AC) clearance. After small incision cataract surgery, difluprednate was superior in clearing AC cells at 1 week (OR=2.5, p>0.00001) and at 2 weeks (OR=2.5, p=0.04), as well as clearing the AC flare at 2 weeks (OR=6.7, p=0.04). After phacoemulsification, difluprednate was superior in terms of corneal clarity at 1 day (OR=2.6, p=0.02) and 1 week after surgery (OR=1.96, p=0.0007). No statistically significant difference was detected between both agents at 1 month in effectiveness. Also, both agents were safe, evaluated by the ocular hypertension (OR=1.23, p=0.8).. With low-to-moderate certainty, difluprednate and prednisolone acetate are safe agents for controlling the inflammation after cataract surgery. Difluprednate showed significant superiority in terms of AC cells and AC flare at 2 weeks postoperatively.

Topics: Animals; Anti-Inflammatory Agents; Cataract Extraction; Fluprednisolone; Humans; Postoperative Care; Postoperative Complications; Prednisolone

To establish whether difluprednate 0.05% nanoemulsion (DIFL) twice a day is as effective as prednisolone acetate 1% + phenylephrine hydrochloride 0.12% suspension (PRED) 4 times a day for postsurgical inflammation treatment.. 4 private Argentine ophthalmological centers.. Noninferiority, prospective, multicenter, double-blind, randomized, parallel-group, comparative trial.. A total of 259 patients who underwent phacoemulsification randomly received DIFL or PRED, starting the day before surgery and continuing for 28 days. The primary endpoint was central corneal thickness. Noninferior anti-inflammatory efficacy was considered if the difference of corneal thickness between baseline and day 4 did not differ beyond 17 μm between treatments. Secondary endpoints were cell and flare, corrected distance visual acuity (CDVA), endothelial cell count, optical coherence tomography (OCT) central macular thickness, and intraocular pressure. All outcomes were evaluated at baseline and day 1, 4, and 28 postoperatively.. 225 patients finished the study. The difference in corneal thickness at baseline and day 4 did not differ beyond 17 μm between treatments (95% CI -2.78 μm to 14.84 μm), with no statistically significant difference ( P = .523). No statistically significant differences were found between groups in total anterior chamber clearance at any study timepoint ( P > .05). Moreover, no statistically significant differences were reported between treatments in CDVA ( P = .455), endothelial cell count ( P = .811), OCT central macular thickness ( P = .869), and intraocular pressure outcome ( P = .316).. Difluprednate administered twice a day was at least as effective as prednisolone acetate administered 4 times a day for inflammatory treatment after cataract surgery.

Topics: Cataract; Eye Diseases; Fluprednisolone; Humans; Inflammation; Phacoemulsification; Postoperative Complications; Prednisolone; Prospective Studies

PurposeTo evaluate safety and efficacy of difluprednate 0.05% ophthalmic emulsion for treatment of postoperative inflammation after cataract surgery in pediatric patients.MethodsThis was a phase 3B, multicentre, randomized, double-masked, active-controlled study of patients aged 0-3 years who underwent uncomplicated cataract surgery in one eye, with/without intraocular lens implantation. Patients were randomized to receive difluprednate 0.05% four times daily or prednisolone acetate 1% for 14 days post surgery, followed by tapering for 14 days. Safety included evaluation of adverse events. Primary efficacy was the proportion of patients with an anterior cell grade of 0 (no cells) at day 14; secondary efficacy was a global inflammation score.ResultsForty patients were randomized to each treatment group. Adverse drug reactions included corneal oedema (difluprednate 0.5%, n=1; prednisolone acetate 1%, n=0) and increased intraocular pressure or ocular hypertension (n=2/group). Mean intraocular pressure values during treatment were 2-3 mm Hg higher with difluprednate 0.05% compared with prednisolone acetate 1%; mean values were similar between groups by the first week after treatment cessation. At 2 weeks post surgery, the incidence of complete clearing of anterior chamber cells was similar between groups (difluprednate 0.05%, n=30 (78.9%); prednisolone acetate 1%, n=31 (77.5%). Compared with prednisolone acetate 1%, approximately twice as many difluprednate 0.05%-treated patients had a global inflammation assessment score indicating no inflammation on day 1 (n=12 (30.8%) vs n=7 (17.5%) and day 8 (n=18 (48.7%) vs n=10 (25.0%).ConclusionsDifluprednate 0.05% four times daily showed safety and efficacy profiles similar to prednisolone acetate 1% four times daily in children 0-3 years undergoing cataract surgery.

Topics: Administration, Topical; Aphakia, Postcataract; Cataract; Cataract Extraction; Child, Preschool; Double-Blind Method; Female; Fluprednisolone; Glucocorticoids; Humans; Infant; Infant, Newborn; Inflammation; Intraocular Pressure; Lens Implantation, Intraocular; Male; Ophthalmic Solutions; Prednisolone; Uveitis, Anterior

Endogenous anterior uveitis (AU), when untreated, may lead to vision loss. This study compared the safety and efficacy of difluprednate versus prednisolone acetate for the treatment of this condition.. This phase III, double-masked, noninferiority study randomized patients with mild to moderate endogenous AU to receive difluprednate 0.05% (n = 56) four times daily, alternating with vehicle four times daily, or prednisolone acetate 1% (n = 54) eight times daily. The 14-day treatment period was followed by a 14-day dose-tapering period and a 14-day observation period. The primary efficacy end point was change in anterior chamber cell grade (range, 0 for ≤1 cell to 4 for >50 cells) from baseline to day 14.. At day 14, the mean change in anterior chamber cell grade with difluprednate was noninferior to that with prednisolone acetate (-2.2 vs. -2.0, P = 0.16). The proportions of difluprednate-treated patients versus prednisolone acetate-treated patients demonstrating complete clearing of anterior chamber cells at day 3 were 13.0% vs. 2.1% (P = 0.046) and at day 21 were 73.9% vs. 63.8% (P = 0.013). A significant between-group difference in the mean IOP increase was seen at day 3 (2.5 mm Hg for difluprednate-treated patients and 0.1 mm Hg for prednisolone acetate-treated patients, P = 0.0013) but not at other time points. The mean IOP values in both groups remained less than 21 mm Hg throughout the study.. Difluprednate 0.05% four times daily is well tolerated and is noninferior to prednisolone acetate 1% eight times daily for the treatment of endogenous AU. (ClinicalTrials.gov number, NCT01201798.).

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Anterior Chamber; Anti-Inflammatory Agents; Child; Double-Blind Method; Drug Administration Schedule; Female; Fluprednisolone; Glucocorticoids; Humans; Intraocular Pressure; Male; Middle Aged; Prednisolone; Uveitis, Anterior; Young Adult

To compare the effects of 2 corticosteroids on corneal thickness and visual acuity after cataract surgery.. Multicenter, randomized, contralateral-eye, double-masked trial.. Fifty-two patients (104 eyes) underwent bilateral phacoemulsification. The first eye randomly received difluprednate 0.05% or prednisolone acetate 1%; the fellow eye received the alternative. Before surgery, 7 doses were administered over 2 hours; 3 additional doses were given after surgery, before discharge. For the remainder of the day, corticosteroids were administered every 2 hours, then 4 times daily during week 1 and twice daily during week 2. Corneal pachymetry, visual acuity, and corneal edema were evaluated before surgery and at days 1, 15, and 30 after surgery. Endothelial cell counts were evaluated before surgery and at 30 days after surgery. Retinal thickness was evaluated before surgery and at 15 and 30 days after surgery.. Corneal thickness at day 1 was 33 μm less in difluprednate-treated eyes (P = .026). More eyes were without corneal edema in the difluprednate group than in the prednisolone group at day 1 (62% vs 38%, respectively; P = .019). Uncorrected and best-corrected visual acuity at day 1 were significantly better with difluprednate than prednisolone by 0.093 logMAR lines (P = .041) and 0.134 logMAR lines (P < .001), respectively. Endothelial cell density was 195.52 cells/mm(2) higher in difluprednate-treated eyes at day 30 (P < .001). Retinal thickness at day 15 was 7.74 μm less in difluprednate-treated eyes (P = .011).. In this high-dose pulsed-therapy regimen, difluprednate reduced inflammation more effectively than prednisolone acetate, resulting in more rapid return of vision. Difluprednate was superior at protecting the cornea and reducing macular thickening after cataract surgery.

Topics: Aged; Aged, 80 and over; Cell Count; Cornea; Corneal Edema; Double-Blind Method; Endothelium, Corneal; Female; Fluprednisolone; Glucocorticoids; Humans; Inflammation; Intraocular Pressure; Lens Implantation, Intraocular; Male; Middle Aged; Phacoemulsification; Prednisolone; Prospective Studies; Pulse Therapy, Drug; Refraction, Ocular; Uveitis, Anterior; Visual Acuity

The aim of this study was to evaluate the efficacy and safety of difluprednate ophthalmic solution 0.05% (Durezol; Alcon Laboratories, Fort Worth, TX) compared with prednisolone acetate ophthalmic suspension 1% (Pred Forte; Allergan, Inc., Irvine, CA) for endogenous anterior uveitis.. In this phase 3, multicenter, randomized, noninferiority trial, 90 patients with endogenous anterior uveitis [>10 anterior chamber (AC) cells and an AC flare score of ≥2 in at least 1 eye] received either difluprednate 4x /day (QID) (n=50) or prednisolone 8x/day (n=40) for 14 days, followed by a 2-week tapering regimen. The main outcome measure was change from baseline in AC cell grade on day 14.. At day 14, mean AC cell grade improvement for difluprednate-treated patients was similar to prednisolone-treated patients (2.1 vs. 1.9, respectively), proving noninferiority. At day 14, 68.8% of difluprednate patients had AC cell clearing (grade 0:≥ 1cell) compared with 61.5% of prednisolone patients. In the prednisolone-treated group, 12.5% of patients were withdrawn because of investigator-determined lack of efficacy; no difluprednate-treated patients were withdrawn for this reason (P=0.01). Clinically significant intraocular pressure elevation occurred in 3 difluprednate-treated patients (6.0%) and 2 prednisolone-treated patients (5.0%).. Difluprednate administered QID is at least as effective as prednisolone administered 8x/day in resolving the inflammation and pain associated with endogenous anterior uveitis. Difluprednate provides effective treatment for anterior uveitis and requires less frequent dosing than prednisolone acetate.. Trial NCT00501579 was registered at the National Institutes of Health Registry in July 2007 ( http://clinicaltrials.gov/ct2/show/NCT00501579?term=sirion&rank=4 ).

Topics: Adult; Anterior Chamber; Anti-Inflammatory Agents; Emulsions; Female; Fluprednisolone; Glucocorticoids; Humans; Intraocular Pressure; Male; Middle Aged; Prednisolone; Suspensions; Treatment Outcome; Uveitis, Anterior; Visual Acuity; Young Adult

To compare the efficacy of 0.05% difluprednate ophthalmic emulsion and 1% prednisolone acetate ophthalmic suspension for controlling aqueocentesis-induced breakdown of the blood-aqueous barrier in healthy dogs.. 34 healthy dogs.. Dogs were allocated to 5 groups (6 to 8 dogs/group) to receive 0.05% difluprednate, 1% prednisolone acetate, or saline (0.9% NaCl) solution (control treatment) in both eyes 2 or 4 times daily. Eye drops were administered topically for 5 consecutive days. Anterior chamber paracentesis (aqueocentesis) was performed in 1 eye on the third day. Automated fluorophotometry was performed immediately before and 20 minutes and 24 and 48 hours after aqueocentesis. Relative fluorescence (RF), defined as fluorescence of the eye that had undergone aqueocentesis divided by fluorescence of the contralateral eye, was calculated to help control for variation among dogs.. Mean RF was significantly lower at 24 hours after aqueocentesis in dogs treated twice daily with 0.05% difluprednate or 4 times daily with 1% prednisolone acetate than in dogs receiving the control treatment. At 48 hours after aqueocentesis, mean RF was significantly lower in dogs treated 4 times daily with 1% prednisolone acetate than in control dogs. Mean RF differed over time in dogs treated 4 times daily with 0.05% difluprednate but did not differ over time for any of the other treatments.. All 4 treatments were effective for reducing aqueocentesis-induced anterior uveitis in healthy dogs regardless of the drug or frequency of administration. Topical ophthalmic administration of 0.05% difluprednate may be a viable treatment option for dogs with anterior uveitis and warrants further study.

Topics: Animals; Blood-Aqueous Barrier; Dogs; Fluprednisolone; Ophthalmic Solutions; Prednisolone

To compare intraocular pressure (IOP) outcomes between 2 common, commercially available corticosteroid drops: difluprednate ophthalmic emulsion 0.05% and prednisolone acetate 1.0%.. TLC Eyecare and Laser Centers, Jackson, Michigan, USA.. Retrospective chart review.. The outcomes of consecutive patients who had uneventful cataract surgery from April 2013 to September 2013 and used prednisolone acetate postoperatively were compared with the outcomes of consecutive patients who had uneventful cataract surgery from June 2014 to October 2014 and used difluprednate postoperatively.. The study included 224 eyes treated with prednisolone acetate 4 times daily for 30 days and 225 eyes treated with difluprednate 2 times daily for 30 days. There was no significant difference between the 2 groups in age, sex, or race. In addition, the mean IOP did not differ significantly between the prednisolone acetate group and the difluprednate group at the preoperative measurement or 1 month after surgery, nor was there a difference in the 1-month change in IOP between groups. No association was found between the incidence of a 6 mm Hg or higher increase in IOP 1 month after surgery and steroid treatment. One month postoperatively, 4 eyes in the prednisolone acetate group and 5 eyes in the difluprednate group had an IOP higher than 21 mm Hg.. There was no significant difference in the mean IOP or percentages showing IOP elevation between eyes treated with difluprednate and eyes treated with prednisolone acetate after cataract surgery. This was likely the result of low-frequency dosing and short duration of steroid use.

Topics: Cataract Extraction; Fluprednisolone; Glucocorticoids; Humans; Incidence; Intraocular Pressure; Ocular Hypertension; Postoperative Complications; Prednisolone; Tonometry, Ocular

Topics: Anti-Inflammatory Agents; Cataract; Cataract Extraction; Child; Double-Blind Method; Fluprednisolone; Humans; Inflammation; Ophthalmic Solutions; Postoperative Complications; Prednisolone

Topics: Anti-Inflammatory Agents; Cataract; Cataract Extraction; Child; Double-Blind Method; Fluprednisolone; Humans; Inflammation; Ophthalmic Solutions; Postoperative Complications; Prednisolone

To identify changes in intraocular pressure (IOP) after vitreoretinal surgical procedures in eyes that received either difluprednate ophthalmic emulsion 0.05% (DP) or prednisolone acetate ophthalmic suspension 1% (PA).. A retrospective chart review compared a consecutive series of 100 patients who received DP with 100 patients who received PA after vitreoretinal surgery. Data were collected for a 3-month period from the time of surgery.. A significantly higher number of patients treated with DP (35%, n = 35) developed increased IOP (>21 mmHg with a change from baseline of >10 mmHg) compared with those receiving PA (22%, n = 22) (P = 0.042). The mean maximum IOP in the DP cohort (26.7 mmHg) was significantly higher than that in the PA cohort (22.8 mmHg) (P = 0.0027). Additionally, the rise in IOP from baseline was significantly higher in the DP-treated cohort (9.0 mmHg) than that in the PA-treated cohort (6.0 mmHg) (P = 0.027).. Eyes treated with DP after vitreoretinal surgery were at increased risk for developing clinically significant increases in IOP compared with those receiving PA.

Topics: Emulsions; Female; Fluprednisolone; Glucocorticoids; Humans; Incidence; Intraocular Pressure; Male; Middle Aged; Ocular Hypertension; Prednisolone; Retrospective Studies; Scleral Buckling; Suspensions; Tonometry, Ocular; Vitrectomy; Vitreoretinal Surgery

To evaluate the effects of graft rejection episodes after Descemet's stripping automated endothelial keratoplasty surgery (DSAEK) on long-term endothelial cell density (ECD) decline and graft survival.. Retrospective, comparative analysis of an interventional case series.. We included 615 eyes of 415 Fuchs' dystrophy patients at a single institution with ≥ 6 months follow-up and without comorbidities known to influence postoperative ECD. All patients were enrolled as part of an ongoing, institutional review board-approved clinical protocol for a long-term, prospective study of endothelial keratoplasty in patients with endothelial dysfunction.. Preoperative specular microscopy of donor corneal tissue was performed. Postoperative specular microscopy measurements were recorded at 6 and 12 months, and yearly thereafter. The percentages of endothelial cell loss recorded at 1, 2, 3, and 4 years were compared with the Mann-Whitney U test.. Percentage ECD declines were calculated at each time point from the results of the preoperative and postoperative specular microscopy. Patients with graft rejection episodes and late endothelial failure were identified. Graft rejection was defined as findings of keratic precipitates with or without corneal edema, or anterior chamber cell and flare with or without corneal edema after the initial resolution of perioperative inflammation.. We identified 45 cases of graft rejection. The greatest number of rejections occurred between postoperative months 12 and 18. Eyes with a graft rejection episode had a higher median percentage decline in ECD at all time points compared with eyes without graft rejection episodes. This was statistically significant at 2 and 3 years postoperatively.. There is a trend toward a greater percentage of ECD loss with time in eyes experiencing graft rejection after DSAEK surgery.. Proprietary or commercial disclosure may be found after the references.

Topics: Aged; Cell Count; Corneal Endothelial Cell Loss; Descemet Stripping Endothelial Keratoplasty; Endothelium, Corneal; Female; Fluprednisolone; Follow-Up Studies; Fuchs' Endothelial Dystrophy; Glucocorticoids; Graft Rejection; Graft Survival; Humans; Male; Postoperative Complications; Prednisolone; Retrospective Studies; Time Factors