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

Figures & data

Table 1 Standardized Grading Scales for Uveitis

Scale Grading Scheme for Anterior Chamber Cells
Grade	Cells in Field
0	No cells
0.5+	1–5
1+	6–15
2+	16–25
3+	26–60
4+	60 +
Visible in a field of 0.2mm × 0.2mm
Scale Grading Scheme for Anterior Chamber Flare
Grade	Description
0	None
1+	Faint
2+	Moderate (iris/lens details clear)
3+	Marked (iris/lens details hazy)
4+	Intense (fibrin/plastic aqueous)

Note: Data from Foster et al.¹⁶

Figure 1 Current flow diagram of patients enrolled in the study.

Table 2 Initial Characteristics of Each Group (n=171 Completed Patients)

	PRO-145 (n=85)	Prednisolone (n=86)	p
Female/Male, n	44/41	49/37	0.541^a
Age, years ± SD (Min–Max)	65.9 ± 11.6 (25–89)	64.7 ± 12.4 (18–85)	0.520^b
VA, LogMAR ± SD (Min–Max)	0.62 ± 0.3 (0.1–1.0)	0.60 ± 0.2 (0.05–1.0)	0.645^b
IOP, mmHg ± SD (Min–Max)	14.9 ± 3.6 (7–23)	15.1 ± 3.1 (8–23)	0.653^b
Retinal OCT, µm ± SD (Min–Max)	243.3 ± 27.4 (167–291)	248.4 ± 25.6 (196–340)	0.248^b
AC cell with grade 0, n (%)	3 (3.5)	2 (2.3)	0.402^c

Notes: ^aFisher exact test, ^bStudent’s t-test, ^cChi square test.

Abbreviations: VA, visual acuity; IOP, intraocular pressure; OCT, optical coherence tomography; AC, anterior chamber.

Table 3 Assessment of Inflammation on Day 29 (PP Population)

Variable	PRO-145 (n=85)	Prednisolone (n=86)	p
AC cell with grade 0, n (%)	75 (88.2)	76 (88.4)	0.621^a
AC flare with grade 0, n (%)	84 (98.8)	86 (100)	0.497^b
Conjunctival hyperemia grade 0, n (%)	78 (91.8)	73 (84.9)	0.300^a
Edema grade 0, n (%)	85 (100)	83 (96.5)	0.246^b
No pain, n (%)	84 (98.8)	86 (100)	0.497^b
No photophobia, n (%)	83 (97.6)	86 (100)	0.359^a

Notes: ^aChi square test, ^bFisher exact test.

Abbreviation: AC, anterior chamber.

Figure 2 Change in intraocular pressure (mmHg) on ITT population. Mean ± SD following PRO-145 (black circle) and prednisolone (black square) treatment after phacoemulsification, p>0.05.

Table 4 Treatment-Related Adverse Events

	PRO-145 (n=88)	Prednisolone (n=90)	Total
Patients with AE, n (%)	55 (62.5)	45 (50)	100 (56.2)
Non-ocular AE, n (%)	4 (4.3)	10 (11.2)	14 (7.7)
Headache, n (%)	0 (0)	3 (30)	3 (21.4)
Flu, n (%)	1 (25)	3 (30)	4 (28.6)
Other, n (%)	3 (75)	4 (40)	7 (50)
Ocular AE, n (%)	89 (95.7)	79 (88.2)	168 (92.3)
Burning, n (%)	46 (51.7)	35 (44.3)	81 (48.2)
Foreign body sensation, n (%)	15 (16.8)	11 (13.9)	26 (15.5)
Itching, n (%)	7 (7.9)	6 (7.6)	13 (7.7)
Blurry vision, n (%)	9 (10.1)	8 (10.1)	17 (10.1)
Ocular hypertension	2 (2.2)	0 (0)	2 (1.2)
CME	0 (0)	2 (2.5)	2 (1.2)
Other, n (%)	10 (11.2)	17 (21.5)	27 (16.1)
Total AE, n (%)	93 (51.1)	89 (48.9)	182 (100)

Notes: Data show frequency (%), n=178 randomized patients (ITT population). No significant differences between groups, all p values (Chi-square Pearson) were p>0.05.

Abbreviations: AE, adverse event; CME, cystoid macular edema.

Foster CS, Vitale AT, editors. Diagnosis and Treatment of Uveitis. Philadelphia: WB Saunders Company; 2002.

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