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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

A comparative confirmatory study of STN1012600 in subjects with primary open angle glaucoma or ocular hypertension

325

[Age (mean plus or minus SD)] 0.002% STN1012600 ophthalmic solution group (hereafter referred to as the STN1012600 group): 62.6 plus or minus 12.60 years 0.005% Latanoprost Ophthalmic Suspension solution group (hereafter referred to as the Latanoprost group): 62.7 plus or minus 13.43 years [Gender] STN1012600 group: 62 males (38.3%), 100 females (61.7%) Latanoprost group: 63 males (38.7%), 100 females (61.3%) [Type of disease] STN1012600 group: 88 subjects of Ocular Hypertension (54.3%), 74 subjects of Primary Open Angle Glaucoma (45.7%) Latanoprost group: 90 subjects of Ocular Hypertension (55.2%), 73 subjects of Primary Open Angle Glaucoma (44.8%) [Mean Diurnal IOP] STN1012600 group: 23.32 plus or minus 1.473 mmHg Latanoprost group: 23.12 plus or minus 1.224 mmHg

[Informed Consent Obtained] 383 subjects [Randomized] 325 subjects (STN1012600 group: 162 subjects, Eye drops group: 163 subjects) [Prematurely discontinued] 15 subjects (STN1012600 group: 6 subjects, Eye drops group: 9 subjects) [Completers] 310 subjects (Cream group: 156 subjects, Eye drops group: 154 subjects)

The incidence of adverse events (AEs) was 53.1% in the STN1012600 group and 41.7% in the latanoprost group, while the incidence of adverse drug reactions (ADRs) was 36.4% and 20.2%, respectively, indicating a higher incidence in the STN1012600 group than in the latanoprost group for both AEs and ADRs. However, AEs of moderate severity were reported in only 3 subjects in the STN1012600 group and 6 subjects in the latanoprost group; all other AEs were mild in severity. The most frequently reported AE and ADR in both groups was conjunctival hyperemia. The incidences of conjunctival hyperemia as an AE and ADR were 31.5% and 29.6%, respectively, in the STN1012600 group, compared with 12.9% and 8.6%, respectively, in the latanoprost group. Therefore, the higher incidence of AEs and ADRs observed in the STN1012600 group compared with the latanoprost group was considered to be mainly attributable to the higher incidence of conjunctival hyperemia. Other frequently reported ADRs were eyelid erythema (2.5%) in the STN1012600 group and eye irritation (4.3%) and punctate keratitis (3.7%) in the latanoprost group. The incidence of all other ADRs was less than 2% in both groups.

Non-inferiority of the STN1012600 group to the latanoprost group was demonstrated for the primary efficacy endpoint, namely the mean change from baseline in mean diurnal intraocular pressure (IOP) at Week 4 after treatment initiation, where mean diurnal IOP was defined as the average of IOP measurements obtained at 9:00, 13:00, and 17:00. Similarly, non-inferiority of the STN1012600 group to the latanoprost group was demonstrated for the secondary efficacy endpoints at Week 2 and Month 3 after treatment initiation. For the important secondary endpoints, namely the changes from baseline in IOP at each measurement time point (9:00, 13:00, and 17:00) at Week 2, Week 4, and Month 3 after treatment initiation, non-inferiority of the STN1012600 group to the latanoprost group was demonstrated at all assessment time points. The proportion of subjects achieving a >=20% reduction in mean diurnal IOP and the proportion of subjects achieving a mean diurnal IOP of <=18 mmHg at Week 4 were statistically significantly lower in the STN1012600 group than in the latanoprost group (P=0.0150 and P=0.0022, respectively). However, for the proportions of subjects achieving a >=25% reduction or a >=30% reduction in mean diurnal IOP at Week 4, as well as for all responder categories at Week 2 and Month 3 after treatment initiation, no statistically significant differences were observed between the treatment groups.

It was demonstrated that STN1012600 ophthalmic solution 0.002% has a non-inferior intraocular pressure-lowering effect compared to latanoprost ophthalmic solution 0.005%. Although the incidence of adverse events and adverse drug reactions was higher with STN1012600 ophthalmic solution 0.002% than with latanoprost ophthalmic solution 0.005%, no safety concerns were identified.

Aug. 31, 2026

June. 16, 2026

https://doi.org/10.1007/s10384-026-01350-3

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031220267

Koji Oka

Santen pharmaceutical co.,ltd

4-20 Ofuka-cho, Kita-ku, Osaka, Japan

clinical@santen.co.jp

Koji Oka

Santen pharmaceutical co.,ltd

4-20 Ofuka-cho, Kita-ku, Osaka, Japan

+81-6-4802-9341

clinical@santen.co.jp

Complete

Aug. 09, 2022

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

18 years of age or older.
Diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better in each eye.

Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye.
History of severe ocular trauma in either eye.
Any condition that prevents clear visualization of the fundus in either eye.
Known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications.
History of ocular surgery specifically intended to lower IOP in either eye.
History of keratorefractive surgery in either eye.
Females who are pregnant, nursing, or planning a pregnancy.
Subjects with known or suspected drug or alcohol abuse.
Participation in other investigational drugs or device clinical trials within 30 days prior to Screening.
Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.

Both

primary open angle glaucoma (POAG) or ocular hypertension (OHT)

STN1012600 0.002% Arm: 1 drop STN1012600 0.002% once daily
Latanoprost 0.005% Arm: 1 drop Latanoprost 0.005% once daily

Change from baseline in mean diurnal intraocular pressure at Week 4

+81-3-5770-1250

June. 30, 2022

none