A phase III study comparing preservative-free latanoprost eye drop emulsion with preserved latanoprost in open-angle glaucoma or ocular hypertension.

• Tác giả: Christophe Baudouin, Rupert Bourne, Jose Manuel Larrosa, Francesco Oddone, Stefanie Schmickler, Aleksey Seleznev, Ingeborg Stalmans
• Ngôn ngữ: eng
• Ký hiệu phân loại: 428.6 Reader (Training college students in reading,readers for new literates, readers for people whose native language is different from the language of the reader --English language
• Thông tin xuất bản: England : Eye (London, England) , 2025
• Bộ sưu tập: NCBI
• ID: 753553

Tóm tắt

 BACKGROUND/OBJECTIVES: To evaluate the efficacy and safety of preservative-free latanoprost eye drop emulsion in reducing intraocular pressure (IOP) versus preserved latanoprost in open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: A Phase III non-inferiority study randomised patients with OAG/OHT 1:1 to receive preservative-free latanoprost eye drop emulsion or preserved latanoprost. The primary efficacy endpoint was change from baseline in peak (9:00 A.M. ± 1 h) and trough (4:00 P.M. ± 1 h) IOP at Week 12 (non-inferiority margin: 95% confidence interval for treatment difference of ≤1.5 mmHg). Key secondary endpoints were change from baseline in corneal fluorescein staining (CFS) score and in ocular surface disease (OSD) average symptom score at Week 12 (in patients with baseline CFS ≥ 1 or OSD score >
  0, respectively). RESULTS: Non-inferiority criteria for IOP-lowering were met. Least square (LS) mean (standard error [SE]) IOP change from baseline with preservative-free latanoprost eye drop emulsion (N = 193) versus preserved latanoprost (N = 193) at Week 12 was -8.8 (0.3) mmHg versus -8.2 (0.3) mmHg at peak (difference: -0.6 mmHg
  nominal p = 0.023)
  -8.6 (0.2) mmHg versus -8.1 (0.3) mmHg at trough (difference: -0.5 mmHg
  p = 0.080). LS mean change in CFS (SE) was -0.7 (0.07) with preservative-free latanoprost eye drop emulsion and -0.4 (0.08) with preserved latanoprost (nominal p <
  0.002). LS mean change in OSD symptom score was -0.3 (0.1) with preservative-free latanoprost eye drop emulsion and -0.2 (0.1) with preserved latanoprost (nominal p = 0.090). CONCLUSIONS: Preservative-free latanoprost eye drop emulsion demonstrated non-inferior IOP-lowering efficacy compared with preserved latanoprost, and improved signs and symptoms of OSD.