CClinicalTrials.gg
Sign In
CompletedNCT05503901Updated Jul 15, 2024

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

A Phase 3 interventional study of STN1012600 ophthalmic solution 0.002% and STN1012600 ophthalmic solution 0.002% in Open Angle Glaucoma, Ocular Hypertension, sponsored by Santen Pharmaceutical Co., Ltd.. Completed at 18 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Santen Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
131
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Open Angle Glaucoma, Ocular Hypertension
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
131 participants (actual)

Study arms

  • Experimental
    Group 1: STN1012600 0.002%

    Drug: STN1012600 ophthalmic solution 0.002%

  • Experimental
    Group 2: STN1012600 0.002%

    Drug: STN1012600 ophthalmic solution 0.002%

  • Experimental
    Group 3: STN1012600 0.002% + Timolol 0.5%

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

Interventions

  • DrugSTN1012600 ophthalmic solution 0.002%

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

  • DrugSTN1012600 ophthalmic solution 0.002%

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

  • DrugSTN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%

    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

05

What researchers measure

Primary outcomes

  1. Change from baseline in mean diurnal intraocular pressure

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

    Time frame: 52 weeks

  2. Percent change from baseline in mean diurnal intraocular pressure

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

    Time frame: 52 weeks

06

Study locations

18 sites
  • Kitanagoya Eye Clinic
    Aichi, Japan
  • Miyake Eye Hospital
    Aichi, Japan
  • Nagasaka Eye Clinic
    Aichi, Japan
  • Eto Eye Clinic
    Fukuoka, Japan
  • Minamoto Eye Clinic
    Hiroshima, Japan
  • Matsumoto Eye Clinic
    Ibaraki, Japan
  • IGO Ophthalmic Clinic
    Kagoshima, Japan
  • Ohguchi Ophthalmic Clinic
    Kanagawa, Japan
  • Smile Eye Clinic
    Kanagawa, Japan
  • Inamoto Eye Clinic
    Osaka, Japan
  • Kubota Eye Clinic
    Osaka, Japan
  • Nishi Eye Hospital
    Osaka, Japan
  • Onoe Eye Clinic
    Osaka, Japan
  • Red Cross Ogawa Hospital
    Saitama, Japan
  • Nakajima Eye Clinic
    Shizuoka, Japan
  • Hashida Eye Clinic
    Tokyo, Japan
  • Seijo Clinic
    Tokyo, Japan
  • Sinzyuku Eye Clinic
    Tokyo, Japan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05503901
Lead sponsor
Santen Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Aug 17, 2022
Start date
Aug 8, 2022
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024
Last update
Jul 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Glaucoma→

Other studies from this sponsor

Santen Pharmaceutical Co., Ltd.

Start the discussion