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

S

Santen

Status and phase

Completed
Phase 3

Conditions

Primary Open Angle Glaucoma, Ocular Hypertension

Treatments

Drug: Latanoprost ophthalmic solution 0.005%
Drug: STN1012600 ophthalmic solution 0.002%

Study type

Interventional

Funder types

Industry

Identifiers

NCT05495061
101260005LT

Details and patient eligibility

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.

Enrollment

325 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

325 participants in 2 patient groups

STN1012600 0.002%
Experimental group
Treatment:
Drug: STN1012600 ophthalmic solution 0.002%
Latanoprost 0.005%
Active Comparator group
Treatment:
Drug: Latanoprost ophthalmic solution 0.005%

Trial contacts and locations

44

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Central trial contact

Santen Pharmaceutical Co., Ltd Clinical Operations

Data sourced from clinicaltrials.gov

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