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NCT05495061

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

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2023-04-18

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Open Angle Glaucoma, Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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STN1012600 0.002%

Group Type EXPERIMENTAL

STN1012600 ophthalmic solution 0.002%

Intervention Type DRUG

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

Latanoprost 0.005%

Group Type ACTIVE_COMPARATOR

Latanoprost ophthalmic solution 0.005%

Intervention Type DRUG

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

Interventions

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STN1012600 ophthalmic solution 0.002%

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

Intervention Type DRUG

Latanoprost ophthalmic solution 0.005%

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

Intervention Type DRUG

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Yamanashi, , Japan

Site Status

Countries

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Japan

Other Identifiers

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101260005LT

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

STN1012600 0.002%

STN1012600 ophthalmic solution 0.002%

Latanoprost 0.005%

Latanoprost ophthalmic solution 0.005%

Interventions

STN1012600 ophthalmic solution 0.002%

Latanoprost ophthalmic solution 0.005%

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Santen Pharmaceutical Co., Ltd.

Responsible Party

Locations

Eyecare Nagoya

Kitanagoya Eye Clinic

Takahashi Eye Clinic

Kawabata Eye Clinic

Mitsuhashi Eye Clinic

Shisui Ophthalmology Clinic

Takeda Eye Clinic

Kanamori Eye Clinic

Dannoue Eye Clinic

Hodogaya iina Eye Clinic

Honda Eye Clinic

Yokosuka Chuoh Eye Clinic

Kengun Sakuragi Eye Clinic

Hideyuki Eye Clinic

Iwashita Eye Clinic

Maeda Eye Clinic

Nishi Eye Hospital

OCROM Clinic

Onoe Eye Clinic

Sugasawa Eye Clinic

Sugiura Eye Clinic

Tahara Eye Clinic

Tane Memorial Eye Hospital

Kawaguchi Aozora Eye Clinic

Omiya Hamada Eye Clinic West entrance Branch

Omiya Hamada Eye Clinic

Shibuya Ophthalmology Clinic

Muramatsu Eye Clinic

Nakamura Eye Clinic

Ono Ophthalmic Clinic

Saito Eye Clinic

Yoshimura Eye & Internal Medical Clinic

Dogenzaka Kato Eye Clinic

Hashida Eye Clinic

Kakinoki Eye Clinic

Seijo Clinic

Shimizu Eye Clinic

Shirayama Eye Clinic

Suitengu Fujita Ophthalmo Clinic

Tamagawa Eye Clinic

Tokiwadai Muranaka Eye Clinic

Ueda Eye Clinic

Watanabe Eye Clinic

IMAI Eye Clinic

Countries

Other Identifiers

101260005LT