Advances in therapy · 2025
A Study of 24-h Efficacy and Safety of Sepetaprost vs. Latanoprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension.
Клиническое исследование II фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Konstas Anastasios-Georgios, Garhöfer Gerhard, Lübke Jan, Voykov Bogomil, Ropo Auli
Аннотация
INTRODUCTION: Understanding the 24-h efficacy and safety of a novel therapy option, sepetaprost ophthalmic solution 0.002% vs. latanoprost ophthalmic solution 0.005%, may delineate its future position in glaucoma treatment.
METHODS: In this exploratory study (EudraCT 2020-004836-93), adults with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) were randomized to sepetaprost or latanoprost for 3 months following a ≤ 35-day screening period. The primary endpoint was mean 24-h intraocular pressure (IOP) at month 3 with sepetaprost vs. latanoprost. Safety outcomes included rate of adverse events (AEs).
RESULTS: Overall, 33 participants received treatment (sepetaprost, n = 17; latanoprost, n = 16). Mean 24-h IOP was numerically lower with sepetaprost vs. latanoprost at month 3 (- 0.88 mmHg; 95% confidence interval [CI] - 2.89, 1.14; not statistically significant at the 0.05 level [NS]). Mean change from baseline in IOP at month 3 ranged from - 5.63 to - 7.00 mmHg for sepetaprost and - 3.84 to - 6.66 mmHg for latanoprost. Lower nocturnal IOP was observed with sepetaprost vs. latanoprost at month 3 (- 1.61 mmHg difference; 95% CI - 4.05, 0.83; not statistically significant; however, the 90% CI was - 5.27, - 0.17 and therefore, nominal statistical significance was achieved at the 0.10 level). Mean difference between groups indicated similar, or numerically lower, IOP with sepetaprost at individual time points at week 6 and month 3. At 36 and 48 h following sepetaprost cessation, mean IOP was lower vs. baseline IOP at the same time points. AEs occurred in 13 (76.5%) vs. 11 (68.8%) participants treated with sepetaprost vs. latanoprost.
CONCLUSION: In participants with POAG or OHT, mean 24-h IOP and nocturnal IOP at month 3 were consistently numerically lower with sepetaprost vs. latanoprost. Safety profiles were similar between groups.
TRIAL REGISTRATION: EudraCT 2020-004836-93.
METHODS: In this exploratory study (EudraCT 2020-004836-93), adults with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) were randomized to sepetaprost or latanoprost for 3 months following a ≤ 35-day screening period. The primary endpoint was mean 24-h intraocular pressure (IOP) at month 3 with sepetaprost vs. latanoprost. Safety outcomes included rate of adverse events (AEs).
RESULTS: Overall, 33 participants received treatment (sepetaprost, n = 17; latanoprost, n = 16). Mean 24-h IOP was numerically lower with sepetaprost vs. latanoprost at month 3 (- 0.88 mmHg; 95% confidence interval [CI] - 2.89, 1.14; not statistically significant at the 0.05 level [NS]). Mean change from baseline in IOP at month 3 ranged from - 5.63 to - 7.00 mmHg for sepetaprost and - 3.84 to - 6.66 mmHg for latanoprost. Lower nocturnal IOP was observed with sepetaprost vs. latanoprost at month 3 (- 1.61 mmHg difference; 95% CI - 4.05, 0.83; not statistically significant; however, the 90% CI was - 5.27, - 0.17 and therefore, nominal statistical significance was achieved at the 0.10 level). Mean difference between groups indicated similar, or numerically lower, IOP with sepetaprost at individual time points at week 6 and month 3. At 36 and 48 h following sepetaprost cessation, mean IOP was lower vs. baseline IOP at the same time points. AEs occurred in 13 (76.5%) vs. 11 (68.8%) participants treated with sepetaprost vs. latanoprost.
CONCLUSION: In participants with POAG or OHT, mean 24-h IOP and nocturnal IOP at month 3 were consistently numerically lower with sepetaprost vs. latanoprost. Safety profiles were similar between groups.
TRIAL REGISTRATION: EudraCT 2020-004836-93.