Loteprednol Etabonate in Ocular Inflammation
Table 1: Summary of Clinical Trials on Efficacy of Loteprednol Etabonate Phase/Study/Design
SAC, phase III trial26
No. Patients Treatments 133
End-points
LE 0.2%, 4x/day, 42 days
Efficacy Findings Reductions in bulbar conjunctival Reduction in bulbar
versus 0.9 vehicle (p<0.001). Itching reduction 3.5 units versus 3.1 units vehicle (p=0.001)
Allergic conjunctivitis, double-masked crossover study27
Prophylaxis of SAC.
Prospective multicenter randomized
placebo-controlled parallel study23 Post-operative
inflammation, double- masked
placebo-controlled3 Post-operative
inflammation, double-
masked placebo-controlled28 Acute anterior uveitis study 116
70 203 227 60
LE 0.2%, versus, olopatadine, 0.1%, 2x/day, 35 days
293
OSDI score, global self-assessment 55% reduction in OSDI score of drug tolerability
in LE group versus 26%
LE 0.5% versus vehicle, Absence of moderate or worse 94% LE group achieved 4x/day, 42 days
signs or symptoms of ocular allergy prophylactic efficiency during peak pollen period.
versus 78% vehicle
Composite scores for itching and group (p=0.001) bulbar injection
LE 0.5% versus vehicle, Resolution of anterior chamber 14 days after
surgery, 4x/day
inflammation at final treatment visit
LE 0.5% versus placebo, Resolution of anterior chamber 14 days after
surgery, 4x/day LE 0.5% versus
inflammation at final treatment visit
Resolution of anterior chamber
prednisolone actetate, inflammation at final 42 days, 8x/day
treatment visit
Acute anterior uveitis study 216
175 LE 0.5% versus Resolution of anterior chamber
prednisolone actetate, inflammation at final 28 days 16x/day
treatment visit
GPC prospective multicenter
double-masked
parallel-group study29 GPC randomized double-masked
parallel-group study30 223 110
by 28 days, 16% free of papillae versus 2% free of papillae in vehicle group
Resolution in 72% LE group versus 87% PA group
Resolution in 64% of LE group Little evidence of IOP and 29% of vehicle group (p<0.001)
elevation or deleterious effects Resolution in 55% of LE
group versus 28% in vehicle group (p<0.001)
Resolution in 74% LE group versus 88% PA group
No IOP elevation of 10mmHg or more
IOP increases ≥10mmHg more
frequent in PA than LE group
IOP increases ≥10mmHg more
frequent in PA than LE group
LE 0.5% versus vehicle, Papillae rated scale zero to three 57% of LE group mild papillae No changes in IOP 28 days, 4x/days
LE 0.5% versus vehicle, Improvement of at least one grade Improvement in papillae 78% of Both well tolerated, 42 days, 4x/day
at final visit in papillae, itching and LE group versus 51% vehicle lens intolerance
no serious or
(p<0.001). Improvement in itching unexpected 95% versus 81% (p<0.001).
Improvement in lens tolerance 87% versus 77% (p=0.053)
GPC randomized double-masked
parallel-group study22 220
LE 0.5% versus vehicle, Improvement of at least one grade Improvement in papillae 75% 42 days, 4x/day
Both well tolerated, no
at final visit in papillae, itching and of LE group versus 50% vehicle serious or unexpected lens tolerance
(p<0.001). Improvement in itching treatment-related events 92% versus 76% (p=0.001). Improvement in lens tolerance 84% versus 66% (p=0.002)
Dry eye with delayed tear clearance,
multicenter randomized placebo-controlled study31
66
LE 0.5% versus vehicle, Combined corneal staining score, Statistically significant 28 days, 4x/day
biomicroscopy findings improvement in both groups
LE group showed significant improvement in nasal bulbar conjunctival injection (P=0.0431)
GPC = giant papillary conjunctivitis; IOP = intraocular pressure; LE = loteprednol etabonate; OSDI = ocular surface disease index; PA = prednisolone acetate; SAC = seasonal allergic conjunctivitis. of IOP elevation (see Figure 1).17,22,30 The efficacy of LE has also been
demonstrated in the prophylactic treatment of SAC when administered six weeks before the onset of the allergy season.23
US OPHTHALMIC REVIEW
A study assessing the efficacy of LE in acute anterior uveitis found significant reductions in symptoms in the LE treatment group, although LE was less effective overall than prednisolone acetate
59
No significant rise in IOP or treatment-
in primary variable (p<0.0001). related events treatment-related events
Less than one on scale of zero to four for
reduction in olopatadine group frequency of stinging, blurry vision and redness No increase of IOP
of 10mmHg or greater
Safety Findings No serious or
injection and itching at two weeks conjunctival injection of 1.3 units unexpected on zero to three point scale
adverse effects
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