Abstract
Purpose :
To evaluate the efficacy and safety of clobetasol propionate ophthalmic nanoemulsion, 0.05% (clobetasol) compared to placebo, when administering one drop four times daily (QID) for 14 days after routine unilateral cataract surgery.
Methods :
Two twin phase III multicenter, randomized, double-masked studies (CLOSE-1 and CLOSE-2) were conducted in the U.S.. Studies were approved by the FDA and a central IRB. 427 patients aged 18 years and older who had undergone routine unilateral cataract surgery and with at least five cells in the anterior chamber (slit lamp on post-operative day one) were randomized (2:1) to the clobetasol or placebo groups. The IMP (clobetasol or placebo) was supplied in sterile single-dose vials to be administered at a dosage of one drop QID for 14 days. No tapering phase was performed.
Patients were monitored for IMP compliance and ophthalmologic assessment on Days 3, 8, 15 and 29.
The primary efficacy endpoint was the percentage of patients with anterior chamber cell (ACC) grade of “0” (absence of cells) at Day 8 to evaluate inflammation. The secondary primary endpoint was the percentage of patients with VAS pain score of “0” at Day 8 to evaluate perceived pain. Safety was assessed by the incidence of adverse events (AE) related to the IMP.
Results :
427 adults were randomized: 281 received clobetasol, 145 placebo and one was not treated.
Absence of cells in the anterior chamber (ACC=0) at Day 8 occurred in 37.8% of clobetasol patients and in 18.1% of placebo patients (p<0.0001).
Pain was totally absent (VAS score=0) at Day 8 in 54.7% of clobetasol patients and in 36.5% of placebo patients (p=0.0005).
Analysis of AE showed that 3.9% of clobetasol patients and 5.5% of placebo patients reported at least one AE related to IMP, with only 1 being serious (cystoid macular edema) in the clobetasol group. Only one patient in each group experienced a moderate increase of their intraocular pressure related to IMP.
Conclusions :
Clobetasol has demonstrated statistical superiority over placebo in reducing inflammation and pain associated with cataract surgery. Clobetasol was found to be safe, effective, well tolerated, and a gradual dosage decrease after 2 weeks of treatment was not found to be necessary.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.