Comparison of a preservative‐free bimatoprost 0.01% ophthalmic gel with a preserved bimatoprost 0.01% ophthalmic solution: A phase III, randomized, multicentre, 3‐month study

Purpose: The aim of this study was to evaluate the intraocular pressure (IOP)‐lowering efficacy and safety of a novel preservative‐free bimatoprost 0.01% ophthalmic gel (PFB 0.01% gel) compared with preserved bimatoprost 0.01% (PB 0.01%) in patients with ocular hypertension (OHT) or glaucoma. Methods: This was a randomized, multicentre (90 centres), investigator‐masked, 3‐month treatment duration, phase III trial. Following a 7‐week run‐in/washout period, patients were randomized to receive once‐daily PFB 0.01% gel (n = 236) or PB 0.01% (n = 249) for 3 months. The primary efficacy measure was change from baseline IOP at Week 12 at 3 timepoints. Noninferiority was based on a predetermined criteria (upper 95% confidence interval margin of 1.5 mmHg at all timepoints). Safety evaluations included conjunctival hyperaemia, ocular symptoms and occurrence of adverse events (AEs). Results: Mean change from baseline in IOP at Week 12 in the PFB 0.01% gel and PB 0.01% were − 9.72 ± 2.97 and − 9.47 ± 3.06 mmHg, respectively at 8 am, −9.41 ± 3.03 and − 9.19 ± 3.12 mmHg at 10 am, and − 8.99 ± 3.36 and − 8.54 ± 3.44 mmHg at 4 pm. Noninferiority of PFB 0.01% gel to PB 0.01% was demonstrated at Week 12 at all timepoints. The percentage of patients experiencing a worsening from baseline in conjunctival hyperaemia score was lower with PFB 0.01% gel compared to PB 0.01% at Week 12 (18.3% vs 30.4%, respectively). Ocular symptoms upon instillation were less frequent in the PFB 0.01% gel group compared to the PB 0.01% group at Week 12 for irritation/burning (12.7% vs 21.2%, respectively), itching (5.4% vs 10.4%) and eye dryness feeling (7.3% vs 14.3%). The most frequent treatment‐related AE was hyperaemia, reported in 15 (6.4%) patients in the PFB 0.01% gel group and 26 (10.4%) patients in the PB 0.01% group. Conclusions: PFB 0.01% ophthalmic gel had the same efficacy in lowering IOP as PB 0.01%, demonstrated less aggravation of conjunctival hyperaemia at Week 12 and less ocular symptoms upon instillation.