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CompletedNCT05495061Updated Dec 5, 2023

A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

A Phase 3 interventional study of STN1012600 ophthalmic solution 0.002% and Latanoprost ophthalmic solution 0.005% in Primary Open Angle Glaucoma, Ocular Hypertension, sponsored by Santen Pharmaceutical Co., Ltd.. Completed at 44 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by Santen Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
325
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks.

02

Conditions studied

  • Primary Open Angle Glaucoma, Ocular Hypertension
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
325 participants (actual)

Study arms

  • Experimental
    STN1012600 0.002%

    Drug: STN1012600 ophthalmic solution 0.002%

  • Active comparator
    Latanoprost 0.005%

    Drug: Latanoprost ophthalmic solution 0.005%

Interventions

  • DrugSTN1012600 ophthalmic solution 0.002%

    1 drop STN1012600 ophthalmic solution 0.002% once daily for 3 months

  • DrugLatanoprost ophthalmic solution 0.005%

    1 drop Latanoprost ophthalmic solution 0.005% once daily for 3 months

05

What researchers measure

Primary outcomes

  1. Change from baseline in mean diurnal intraocular pressure

    Change from baseline in mean diurnal intraocular pressure at Week 4

    Time frame: 4 weeks

06

Study locations

44 sites
  • Eyecare Nagoya
    Aichi, Japan
  • Kitanagoya Eye Clinic
    Aichi, Japan
  • Takahashi Eye Clinic
    Aichi, Japan
  • Kawabata Eye Clinic
    Chiba, Japan
  • Mitsuhashi Eye Clinic
    Chiba, Japan
  • Shisui Ophthalmology Clinic
    Chiba, Japan
  • Takeda Eye Clinic
    Hokkaido, Japan
  • Kanamori Eye Clinic
    Hyogo, Japan
  • Dannoue Eye Clinic
    Kanagawa, Japan
  • Hodogaya iina Eye Clinic
    Kanagawa, Japan
  • Honda Eye Clinic
    Kanagawa, Japan
  • Yokosuka Chuoh Eye Clinic
    Kanagawa, Japan
  • Kengun Sakuragi Eye Clinic
    Kumamoto, Japan
  • Hideyuki Eye Clinic
    Miyagi, Japan
  • Iwashita Eye Clinic
    Osaka, Japan
  • Maeda Eye Clinic
    Osaka, Japan
  • Nishi Eye Hospital
    Osaka, Japan
  • OCROM Clinic
    Osaka, Japan
  • Onoe Eye Clinic
    Osaka, Japan
  • Sugasawa Eye Clinic
    Osaka, Japan
  • Sugiura Eye Clinic
    Osaka, Japan
  • Tahara Eye Clinic
    Osaka, Japan
  • Tane Memorial Eye Hospital
    Osaka, Japan
  • Kawaguchi Aozora Eye Clinic
    Saitama, Japan
  • Omiya Hamada Eye Clinic West entrance Branch
    Saitama, Japan
  • Omiya Hamada Eye Clinic
    Saitama, Japan
  • Shibuya Ophthalmology Clinic
    Saitama, Japan
  • Muramatsu Eye Clinic
    Shizuoka, Japan
  • Nakamura Eye Clinic
    Shizuoka, Japan
  • Ono Ophthalmic Clinic
    Shizuoka, Japan
  • Saito Eye Clinic
    Shizuoka, Japan
  • Yoshimura Eye & Internal Medical Clinic
    Shizuoka, Japan
  • Dogenzaka Kato Eye Clinic
    Tokyo, Japan
  • Hashida Eye Clinic
    Tokyo, Japan
  • Kakinoki Eye Clinic
    Tokyo, Japan
  • Seijo Clinic
    Tokyo, Japan
  • Shimizu Eye Clinic
    Tokyo, Japan
  • Shirayama Eye Clinic
    Tokyo, Japan
  • Suitengu Fujita Ophthalmo Clinic
    Tokyo, Japan
  • Tamagawa Eye Clinic
    Tokyo, Japan
  • Tokiwadai Muranaka Eye Clinic
    Tokyo, Japan
  • Ueda Eye Clinic
    Tokyo, Japan
  • Watanabe Eye Clinic
    Tokyo, Japan
  • IMAI Eye Clinic
    Yamanashi, Japan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05495061
Lead sponsor
Santen Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Aug 10, 2022
Start date
Aug 9, 2022
Primary completion
Apr 18, 2023
Completion
Apr 18, 2023
Last update
Dec 5, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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