DOI: 10.1097/ijg.0000000000002371 ISSN: 1057-0829

Preservative-free Bimatoprost 0.01% Ophthalmic Gel for Glaucoma Therapy. A Phase III Randomized Controlled Trial

Francisco J Muñoz-Negrete, Fotis Topouzis, Francesco Oddone, Sylvie Nisslé, Dariusz Rokicki, Ingrida Januleviciene, Paul Harasymowycz, Ingeborg Stalmans
  • Ophthalmology
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Purpose:

To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of a preservative-free bimatoprost 0.01% ophthalmic gel (PFB 0.01% gel) compared with preserved bimatoprost 0.01% (PB 0.01%).

Design:

Phase III, international, multicenter, randomized, 2-parallel group, investigator-masked, 3-month treatment duration.

Methods:

Patients with glaucoma or ocular hypertension were randomized after a 7 week run-in/washout period 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 in IOP at Week 12. Safety measures included adverse events (AEs) and assessment of conjunctival hyperemia.

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 mmHg and -9.47±3.06, 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 based on predetermined criteria (upper 95% confidence interval margin of 1.5 mmHg at all timepoints). The most frequently reported AE was conjunctival hyperemia; 13 (5.5%) patients with PFB 0.01% gel and 17 (6.8%) patients with PB 0.01%. The percentage of patients experiencing a worsening from baseline in conjunctival hyperemia score was lower with PFB 0.01% gel compared to PB 0.01% at Week 6 (20.1% vs 29.3%, respectively) and Week 12 (18.3% vs 30.4%, respectively).

Conclusions:

PFB 0.01% ophthalmic gel has the same efficacy in lowering IOP as PB 0.01% and demonstrated less aggravation of conjunctival hyperemia at Week 6 and Week 12.

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