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OpenTrials
Completed

NCT Number: NCT05503901

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

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.

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Key information

Conditions

Open Angle Glaucoma, Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kitanagoya Eye Clinic, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 in each eye.

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.

Treatment and study plan

STN1012600 ophthalmic solution 0.002%

Drug

1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks

STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%

Drug

1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks and 1 drop Timolol ophthalmic solution 0.5% twice daily for 52 weeks

Primary outcomes

  1. Change from baseline in mean diurnal intraocular pressure

    Time frame: 52 weeks

    Change from baseline in mean diurnal intraocular pressure at each post-baseline visit

  2. Percent change from baseline in mean diurnal intraocular pressure

    Time frame: 52 weeks

    Percent change from baseline in mean diurnal intraocular pressure at each post-baseline visit

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-Label, Long-Term Phase III Study of STN1012600 Ophthalmic Solution Alone and in Combination With Timolol Ophthalmic Solution, in Subjects With Open Angle Glaucoma or Ocular Hypertension (Angel-J2 Study)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2022
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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