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fluprednisolone and Uveitis, Anterior

fluprednisolone has been researched along with Uveitis, Anterior in 10 studies

Fluprednisolone: A synthetic glucocorticoid with anti-inflammatory properties.

Uveitis, Anterior: Inflammation of the anterior uvea comprising the iris, angle structures, and the ciliary body. Manifestations of this disorder include ciliary injection, exudation into the anterior chamber, iris changes, and adhesions between the iris and lens (posterior synechiae). Intraocular pressure may be increased or reduced.

Research Excerpts

ExcerptRelevanceReference
"Difluprednate given 2 or 4 times a day cleared postoperative inflammation and reduced pain rapidly and effectively."9.14Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. ( Cooke, DL; Crockett, RS; Korenfeld, MS; Silverstein, SM; Vogel, R, 2009)
"To describe the use of topical difluprednate for the treatment of uveitic macular edema."7.83Topical difluprednate monotherapy for uveitic macular edema. ( Forooghian, F; Symes, RJ, 2016)
" Safety included evaluation of adverse events."6.82Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study. ( Gedif, K; Lambert, SR; Markwardt, K; O'Halloran, H; Plager, DA; Roarty, J; VanderVeen, D; Wilson, ME, 2016)
"In this high-dose pulsed-therapy regimen, difluprednate reduced inflammation more effectively than prednisolone acetate, resulting in more rapid return of vision."5.15A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery. ( Donnenfeld, ED; Fiore, J; Gobbo, A; Holland, EJ; Perry, HD; Prince, J; Sandoval, HP; Shull, ER; Solomon, KD, 2011)
"Difluprednate given 2 or 4 times a day cleared postoperative inflammation and reduced pain rapidly and effectively."5.14Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. ( Cooke, DL; Crockett, RS; Korenfeld, MS; Silverstein, SM; Vogel, R, 2009)
"To describe the use of topical difluprednate for the treatment of uveitic macular edema."3.83Topical difluprednate monotherapy for uveitic macular edema. ( Forooghian, F; Symes, RJ, 2016)
" Safety included evaluation of adverse events."2.82Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study. ( Gedif, K; Lambert, SR; Markwardt, K; O'Halloran, H; Plager, DA; Roarty, J; VanderVeen, D; Wilson, ME, 2016)
" Difluprednate provides effective treatment for anterior uveitis and requires less frequent dosing than prednisolone acetate."2.75Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis. ( Crockett, RS; Davanzo, R; Flynn, TE; Foster, CS; McLeod, K; Vogel, R, 2010)
"Difluprednate 0."1.36Intraocular pressure elevation from topical difluprednate use. ( Meehan, K; Sowka, J; Vollmer, L, 2010)

Research

Studies (10)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (10.00)29.6817
2010's9 (90.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Sheppard, JD1
Toyos, MM1
Kempen, JH1
Kaur, P1
Foster, CS3
Abu Samra, K1
Valdes-Navarro, M1
Lee, S1
Swan, R1
Anesi, SD1
Symes, RJ1
Forooghian, F1
Wilson, ME1
O'Halloran, H1
VanderVeen, D1
Roarty, J1
Plager, DA1
Markwardt, K1
Gedif, K1
Lambert, SR1
Korenfeld, MS1
Silverstein, SM1
Cooke, DL1
Vogel, R2
Crockett, RS2
Davanzo, R1
Flynn, TE1
McLeod, K1
Meehan, K1
Vollmer, L1
Sowka, J1
Donnenfeld, ED1
Holland, EJ1
Solomon, KD1
Fiore, J1
Gobbo, A1
Prince, J1
Sandoval, HP1
Shull, ER1
Perry, HD1
Oltra, EZ1
Morris, C1
Birnbaum, AD1
Tessler, HH1
Goldstein, DA1
Liu, MP1
Hwang, FS1
Dunn, JP1
Stark, WJ1
Bower, KS1

Clinical Trials (6)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis[NCT01201798]Phase 3111 participants (Actual)Interventional2010-10-31Completed
A Prospective, Multi-center, Controlled, Double-blind Study to Evaluate the Efficacy and Tolerability of a Steroid/Antibiotic Associated Treatment Following Cataract Extraction by Means of Phaco-emulsification[NCT02973880]Phase 3180 participants (Actual)Interventional2017-10-15Completed
A Phase 3 Multicenter, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Difluprednate in the Treatment of Inflammation Following Ocular Surgery[NCT00429923]Phase 3219 participants (Actual)InterventionalCompleted
A Phase 3 Multicenter, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Difluprednate in the Treatment of Inflammation Following Ocular Surgery[NCT00430092]Phase 3219 participants (Actual)InterventionalCompleted
[NCT00501579]Phase 30 participants InterventionalCompleted
A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal [NCT01244334]Phase 452 participants (Actual)Interventional2009-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Proportion of Subjects Who Discontinued Due to Lack of Efficacy

Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Time to Event

InterventionPercentage of subjects (Number)
Durezol0
Pred Forte14.9

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 21Day 28Day 35Day 42
Durezol2.6-1.1-1.8-2.4-2.3-2.3-2.3
Pred Forte2.6-1.0-1.6-2.1-2.1-2.1-2.1

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. (NCT01201798)
Timeframe: Baseline (Day 0), Day 14

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 14
Durezol2.6-2.2
Pred Forte2.6-2.0

Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points

Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol2.2-1.1-1.6-2.0-2.0-2.0-2.0-2.0
Pred Forte2.3-1.2-1.6-1.9-2.0-2.0-2.0-2.0

Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits

The following signs were each graded on a 0 - 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol7.1-3.5-5.2-6.1-6.5-6.4-6.3-6.2
Pred Forte7.3-3.6-5.0-5.8-6.2-6.2-6.2-6.3

Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points

The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol186.7-88.4-108.2-133.3-138.8-140.1-143.9-146.2
Pred Forte203.2-88.4-123.8-137.4-149.5-152.4-147.3-155.5

Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol13.041.378.382.680.482.680.4
Pred Forte14.940.461.776.676.676.678.7

Proportion of Subjects With Anterior Chamber Cell Count of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol13.021.752.273.973.969.669.6
Pred Forte2.121.338.348.963.863.868.1

Proportion of Subjects With Anterior Chamber Cell Grade ≤1

As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol50.087.093.593.593.593.591.3
Pred Forte57.480.985.189.487.285.185.1

Proportion of Subjects With Anterior Chamber Cell Grade of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol15.234.865.284.880.478.376.1
Pred Forte6.425.555.363.870.270.274.5

"Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo)."

"Measured on a 0 to 4 scale: 0 is ≤ 1 cell; 1 is 2-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells." (NCT00429923)
Timeframe: Day 8 (QID)

,,
Interventionparticipants (Number)
Proportion of subjects w/AC cell grade=0 on Day 8
Difluprednate 0.05% BID0
Difluprednate 0.05% QID19
Placebo13

"Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo)."

"Measured on a 0 to 4 scale: 0 is ≤ 1 cell; 1 is 2-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells." (NCT00430092)
Timeframe: Day 8 (QID)

,,
Interventionparticipants (Number)
Proportion of Subjects w/AC cell grade=0 on Day 8
Difluprednate 0.05% BID0
Difluprednate 0.05% QID18
Placebo7

Trials

5 trials available for fluprednisolone and Uveitis, Anterior

ArticleYear
Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study.
    Investigative ophthalmology & visual science, 2014, May-06, Volume: 55, Issue:5

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Anterior Chamber; Anti-Inflammator

2014
Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study.
    Eye (London, England), 2016, Volume: 30, Issue:9

    Topics: Administration, Topical; Aphakia, Postcataract; Cataract; Cataract Extraction; Child, Preschool; Dou

2016
Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
    Journal of cataract and refractive surgery, 2009, Volume: 35, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Anterior Chamber; Cell Count; Double-Blind Method; Emulsions; Female

2009
Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
    Journal of cataract and refractive surgery, 2009, Volume: 35, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Anterior Chamber; Cell Count; Double-Blind Method; Emulsions; Female

2009
Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
    Journal of cataract and refractive surgery, 2009, Volume: 35, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Anterior Chamber; Cell Count; Double-Blind Method; Emulsions; Female

2009
Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
    Journal of cataract and refractive surgery, 2009, Volume: 35, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Anterior Chamber; Cell Count; Double-Blind Method; Emulsions; Female

2009
Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
    Journal of cataract and refractive surgery, 2009, Volume: 35, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Anterior Chamber; Cell Count; Double-Blind Method; Emulsions; Female

2009
Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
    Journal of cataract and refractive surgery, 2009, Volume: 35, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Anterior Chamber; Cell Count; Double-Blind Method; Emulsions; Female

2009
Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
    Journal of cataract and refractive surgery, 2009, Volume: 35, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Anterior Chamber; Cell Count; Double-Blind Method; Emulsions; Female

2009
Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
    Journal of cataract and refractive surgery, 2009, Volume: 35, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Anterior Chamber; Cell Count; Double-Blind Method; Emulsions; Female

2009
Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain.
    Journal of cataract and refractive surgery, 2009, Volume: 35, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Anterior Chamber; Cell Count; Double-Blind Method; Emulsions; Female

2009
Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis.
    Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics, 2010, Volume: 26, Issue:5

    Topics: Adult; Anterior Chamber; Anti-Inflammatory Agents; Emulsions; Female; Fluprednisolone; Glucocorticoi

2010
A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery.
    American journal of ophthalmology, 2011, Volume: 152, Issue:4

    Topics: Aged; Aged, 80 and over; Cell Count; Cornea; Corneal Edema; Double-Blind Method; Endothelium, Cornea

2011

Other Studies

5 other studies available for fluprednisolone and Uveitis, Anterior

ArticleYear
A case of bilateral uveitis and papillitis in a patient treated with pembrolizumab.
    European journal of ophthalmology, 2016, Apr-12, Volume: 26, Issue:3

    Topics: Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Fluprednisolone; Glucoc

2016
Topical difluprednate monotherapy for uveitic macular edema.
    Canadian journal of ophthalmology. Journal canadien d'ophtalmologie, 2016, Volume: 51, Issue:1

    Topics: Administration, Topical; Adult; Female; Fluprednisolone; Glucocorticoids; Humans; Macular Edema; Mal

2016
Intraocular pressure elevation from topical difluprednate use.
    Optometry (St. Louis, Mo.), 2010, Volume: 81, Issue:12

    Topics: Administration, Topical; Black or African American; Emulsions; Female; Fluprednisolone; Glucocortico

2010
Chronic anterior uveitis in common variable immunodeficiency.
    Ocular immunology and inflammation, 2011, Volume: 19, Issue:6

    Topics: Adrenal Cortex Hormones; Anti-Inflammatory Agents; Antibodies, Monoclonal; Child; Chronic Disease; C

2011
Hypopyon uveitis following LASIK in a patient with ulcerative colitis.
    Journal of refractive surgery (Thorofare, N.J. : 1995), 2012, Volume: 28, Issue:8

    Topics: Administration, Oral; Administration, Topical; Astigmatism; Colitis, Ulcerative; Fluprednisolone; Gl

2012