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

Last updated: December 3, 2023
Sponsor: Santen Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Williams Syndrome

Glaucoma

Stress

Treatment

Latanoprost ophthalmic solution 0.005%

STN1012600 ophthalmic solution 0.002%

Clinical Study ID

NCT05495061
101260005LT
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 eacheye.

Exclusion

Exclusion Criteria:

  • Presence of any active severe external ocular disease, inflammation, or infection ofthe 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 studymedications 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 daysprior to Screening.
  • Any decision by the Investigator to terminate a subject in screening or declare anysubject ineligible for any sound medical reason.

Study Design

Total Participants: 325
Treatment Group(s): 2
Primary Treatment: Latanoprost ophthalmic solution 0.005%
Phase: 3
Study Start date:
August 09, 2022
Estimated Completion Date:
April 18, 2023

Connect with a study center

  • Eyecare Nagoya

    Aichi,
    Japan

    Site Not Available

  • Kitanagoya Eye Clinic

    Aichi,
    Japan

    Site Not Available

  • Takahashi Eye Clinic

    Aichi,
    Japan

    Site Not Available

  • Kawabata Eye Clinic

    Chiba,
    Japan

    Site Not Available

  • Mitsuhashi Eye Clinic

    Chiba,
    Japan

    Site Not Available

  • Shisui Ophthalmology Clinic

    Chiba,
    Japan

    Site Not Available

  • Takeda Eye Clinic

    Hokkaido,
    Japan

    Site Not Available

  • Kanamori Eye Clinic

    Hyogo,
    Japan

    Site Not Available

  • Dannoue Eye Clinic

    Kanagawa,
    Japan

    Site Not Available

  • Hodogaya iina Eye Clinic

    Kanagawa,
    Japan

    Site Not Available

  • Honda Eye Clinic

    Kanagawa,
    Japan

    Site Not Available

  • Yokosuka Chuoh Eye Clinic

    Kanagawa,
    Japan

    Site Not Available

  • Kengun Sakuragi Eye Clinic

    Kumamoto,
    Japan

    Site Not Available

  • Hideyuki Eye Clinic

    Miyagi,
    Japan

    Site Not Available

  • Iwashita Eye Clinic

    Osaka,
    Japan

    Site Not Available

  • Maeda Eye Clinic

    Osaka,
    Japan

    Site Not Available

  • Nishi Eye Hospital

    Osaka,
    Japan

    Site Not Available

  • OCROM Clinic

    Osaka,
    Japan

    Site Not Available

  • Onoe Eye Clinic

    Osaka,
    Japan

    Site Not Available

  • Sugasawa Eye Clinic

    Osaka,
    Japan

    Site Not Available

  • Sugiura Eye Clinic

    Osaka,
    Japan

    Site Not Available

  • Tahara Eye Clinic

    Osaka,
    Japan

    Site Not Available

  • Tane Memorial Eye Hospital

    Osaka,
    Japan

    Site Not Available

  • Kawaguchi Aozora Eye Clinic

    Saitama,
    Japan

    Site Not Available

  • Omiya Hamada Eye Clinic

    Saitama,
    Japan

    Site Not Available

  • Omiya Hamada Eye Clinic West entrance Branch

    Saitama,
    Japan

    Site Not Available

  • Shibuya Ophthalmology Clinic

    Saitama,
    Japan

    Site Not Available

  • Muramatsu Eye Clinic

    Shizuoka,
    Japan

    Site Not Available

  • Nakamura Eye Clinic

    Shizuoka,
    Japan

    Site Not Available

  • Ono Ophthalmic Clinic

    Shizuoka,
    Japan

    Site Not Available

  • Saito Eye Clinic

    Shizuoka,
    Japan

    Site Not Available

  • Yoshimura Eye & Internal Medical Clinic

    Shizuoka,
    Japan

    Site Not Available

  • Dogenzaka Kato Eye Clinic

    Tokyo,
    Japan

    Site Not Available

  • Hashida Eye Clinic

    Tokyo,
    Japan

    Site Not Available

  • Kakinoki Eye Clinic

    Tokyo,
    Japan

    Site Not Available

  • Seijo Clinic

    Tokyo,
    Japan

    Site Not Available

  • Shimizu Eye Clinic

    Tokyo,
    Japan

    Site Not Available

  • Shirayama Eye Clinic

    Tokyo,
    Japan

    Site Not Available

  • Suitengu Fujita Ophthalmo Clinic

    Tokyo,
    Japan

    Site Not Available

  • Tamagawa Eye Clinic

    Tokyo,
    Japan

    Site Not Available

  • Tokiwadai Muranaka Eye Clinic

    Tokyo,
    Japan

    Site Not Available

  • Ueda Eye Clinic

    Tokyo,
    Japan

    Site Not Available

  • Watanabe Eye Clinic

    Tokyo,
    Japan

    Site Not Available

  • IMAI Eye Clinic

    Yamanashi,
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.