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

NCT05503901 | Completed Phase 3

• 1 other identifier: 101260006LT
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Open Angle Glaucoma, Ocular Hypertension

Outcome Measures

Primary Outcomes (2)

• Change from baseline in mean diurnal intraocular pressure

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

  52 weeks

• Percent change from baseline in mean diurnal intraocular pressure

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

  52 weeks

Study Arms (3)

Group 1: STN1012600 0.002%

EXPERIMENTAL

Drug: STN1012600 ophthalmic solution 0.002%

Group 2: STN1012600 0.002%

EXPERIMENTAL

Drug: STN1012600 ophthalmic solution 0.002%

Group 3: STN1012600 0.002% + Timolol 0.5%

EXPERIMENTAL

Drug: STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%

Interventions

STN1012600 ophthalmic solution 0.002% DRUG

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

Group 1: STN1012600 0.002%

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

Group 3: STN1012600 0.002% + Timolol 0.5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santen Pharmaceutical Co., Ltd.: lead

Study Sites (18)

Kitanagoya Eye Clinic

Aichi, Japan

Location

Miyake Eye Hospital

Aichi, Japan

Location

Nagasaka Eye Clinic

Aichi, Japan

Location

Eto Eye Clinic

Fukuoka, Japan

Location

Minamoto Eye Clinic

Hiroshima, Japan

Location

Matsumoto Eye Clinic

Ibaraki, Japan

Location

IGO Ophthalmic Clinic

Kagoshima, Japan

Location

Ohguchi Ophthalmic Clinic

Kanagawa, Japan

Location

Smile Eye Clinic

Kanagawa, Japan

Location

Inamoto Eye Clinic

Osaka, Japan

Location

Kubota Eye Clinic

Osaka, Japan

Location

Nishi Eye Hospital

Osaka, Japan

Location

Onoe Eye Clinic

Osaka, Japan

Location

Red Cross Ogawa Hospital

Saitama, Japan

Location

Nakajima Eye Clinic

Shizuoka, Japan

Location

Hashida Eye Clinic

Tokyo, Japan

Location

Seijo Clinic

Tokyo, Japan

Location

Sinzyuku Eye Clinic

Tokyo, Japan

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 17, 2022
• Study Start: August 8, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (18)