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

Santen

Status and phase: Completed; Phase 3

Conditions: Open Angle Glaucoma, Ocular Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05503901

101260006LT

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 3 patient groups

Group 1: STN1012600 0.002%

Experimental group

Treatment:

Drug: STN1012600 ophthalmic solution 0.002%

Drug: STN1012600 ophthalmic solution 0.002%

Group 2: STN1012600 0.002%

Experimental group

Treatment:

Drug: STN1012600 ophthalmic solution 0.002%

Drug: STN1012600 ophthalmic solution 0.002%

Group 3: STN1012600 0.002% + Timolol 0.5%

Experimental group

Treatment:

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