Lotemax Gel (Loteprednol 0.5%)

Approved uses

Post-operative inflammation and pain after cataract surgery

1 to 2 drops into the conjunctival sac of the affected eye QID beginning the day after surgery, continuing through the first 2 post-operative weeks

By day 8, 74% are pain free and 31% have complete anterior chamber cell clearance.

Post-cataract-surgery inflammation in children 11 years and younger

Labeled regimen applies: 1 to 2 drops QID beginning the day after surgery through the first 2 post-operative weeks. The supporting pediatric trial instead used twice on the day of surgery, then QID for 2 weeks, BID for 1 week, and QD for 1 week

Matches prednisolone acetate 1% for day-14 inflammation in children 11 and under.

OFF-LABELNot in the FDA label for this product

Corticosteroid prophylaxis after photorefractive keratectomy

QID for 1 week, then TID for 3 weeks, then BID for 1 month, then QD for 1 month

Comparative trial · n=132

Single-center prospective, randomized, partially masked trial, 261 eyes of 132 patients, comparing this 3-month gel taper with prednisolone acetate 1% tapered to fluorometholone 0.1%; examiners were masked for IOP and haze grading. Corneal haze in the first 3 months occurred in 3 of 114 eyes on gel versus 7 of 147 on the comparator, and an IOP rise of 10 mmHg or more above baseline or any IOP above 21 mmHg in 2 of 114 versus 6 of 147; neither difference reached statistical significance. Visual and refractive results were equivalent, and the authors concluded only that the gel taper is clinically noninferior, not superior.

Mifflin MD, Betts BS, Frederick PA, Feuerman JM, Fenzl CR, Moshirfar M, Zaugg B. Efficacy and safety of a 3-month loteprednol etabonate 0.5% gel taper for routine prophylaxis after photorefractive keratectomy compared to a 3-month prednisolone acetate 1% and fluorometholone 0.1% taper. Clin Ophthalmol. 2017;11:1113-1118. PubMed indexes it as a Journal Article, not as a randomized controlled trial, although the report describes randomization. The taper is from the article's Materials and methods.

Lotemax Gel (Loteprednol 0.5%) | EyeKnow O.D.