A Long Term Study of STN1012600 in Subjects With Open Angle Glaucoma or Ocular Hypertension

Last updated: July 12, 2024
Sponsor: Santen Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Ocular Hypertension

Stress

Circulation Disorders

Treatment

STN1012600 ophthalmic solution 0.002%

STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%

Clinical Study ID

NCT05503901
101260006LT
  • Ages > 18
  • All Genders

Study Summary

To evaluate safety and the ocular hypotensive effect of STN1012600 ophthalmic solution 0.002% alone or in combination with Timolol ophthalmic solution 0.5% for 52 weeks in subjects with open angle glaucoma or ocular hypertension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older.

  • Diagnosis of OAG or OHT in both eyes, or one eye with OAG and the other with OHT.

  • Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better ineach eye.

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 30days prior 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: 131
Treatment Group(s): 2
Primary Treatment: STN1012600 ophthalmic solution 0.002%
Phase: 3
Study Start date:
August 08, 2022
Estimated Completion Date:
January 30, 2024

Connect with a study center

  • Kitanagoya Eye Clinic

    Aichi,
    Japan

    Site Not Available

  • Miyake Eye Hospital

    Aichi,
    Japan

    Site Not Available

  • Nagasaka Eye Clinic

    Aichi,
    Japan

    Site Not Available

  • Eto Eye Clinic

    Fukuoka,
    Japan

    Site Not Available

  • Minamoto Eye Clinic

    Hiroshima,
    Japan

    Site Not Available

  • Matsumoto Eye Clinic

    Ibaraki,
    Japan

    Site Not Available

  • IGO Ophthalmic Clinic

    Kagoshima,
    Japan

    Site Not Available

  • Ohguchi Ophthalmic Clinic

    Kanagawa,
    Japan

    Site Not Available

  • Smile Eye Clinic

    Kanagawa,
    Japan

    Site Not Available

  • Inamoto Eye Clinic

    Osaka,
    Japan

    Site Not Available

  • Kubota Eye Clinic

    Osaka,
    Japan

    Site Not Available

  • Nishi Eye Hospital

    Osaka,
    Japan

    Site Not Available

  • Onoe Eye Clinic

    Osaka,
    Japan

    Site Not Available

  • Red Cross Ogawa Hospital

    Saitama,
    Japan

    Site Not Available

  • Nakajima Eye Clinic

    Shizuoka,
    Japan

    Site Not Available

  • Hashida Eye Clinic

    Tokyo,
    Japan

    Site Not Available

  • Seijo Clinic

    Tokyo,
    Japan

    Site Not Available

  • Sinzyuku Eye Clinic

    Tokyo,
    Japan

    Site Not Available

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