Trial reportJapanese journal of ophthalmology2026
Efficacy and safety of sepetaprost in patients with primary open-angle glaucoma or ocular hypertension: results from the randomised, phase 3 ANGEL-J1 study.
Trial report in Japanese journal of ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05495061 (A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared With Latanoprost 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared With Latanoprost 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (Angel-J1 Study)
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo evaluate the efficacy and safety of sepetaprost, a novel dual FP/EP3 receptor agonist, in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). STUDY
designANGEL-J1 (NCT05495061) was a phase 3, randomised, investigator-masked, active-controlled, parallel-group, non-inferiority study across 49 sites in Japan.
methodsAdults with POAG or OHT were randomised 1:1 to topical sepetaprost 0.002% or latanoprost 0.005%, once daily for 3 months. The primary endpoint was change in mean diurnal intraocular pressure (IOP) from baseline at week 4 (non-inferiority margin, 1.5 mmHg); a key secondary endpoint was mean change in IOP from baseline over 3 months. Safety outcomes included the incidence of adverse drug reactions (ADRs).
resultsIn total, 325 patients were randomised to sepetaprost (n=162) or latanoprost (n=163). In mixed model for repeated measures analyses, ANGEL-J1 met its primary endpoint; the least-squares mean (± standard error) change in mean diurnal IOP from baseline at week 4 was -5.77±0.16 mmHg in the sepetaprost group, which was non-inferior to -6.10±0.16 mmHg in the latanoprost group (least-squares mean difference, 0.32 mmHg [95% confidence interval, -0.12, 0.77]). Non-inferiority for the key secondary endpoint was also established, with comparable mean reductions in IOP between groups maintained over 3 months. ADRs occurred in 59 patients (36.4%) receiving sepetaprost and 33 (20.2%) receiving latanoprost; the most common ADR was conjunctival hyperaemia (29.6% and 8.6%, respectively; mostly mild in severity).
conclusionIn patients with POAG or OHT, sepetaprost demonstrated IOP-lowering efficacy that was non-inferior to latanoprost, and an acceptable safety profile.
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