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

Sponsored by Santen Pharmaceutical Co., Ltd.

About this trial

Last updated 3 years ago

Study ID

101260005LT

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

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