A Study to Investigate the Effect of IOP-lowering With TO-O-1001 Eye Drops in Healthy Subjects and in Patients With Open-Angle Glaucoma or Ocular Hypertension

Last updated: October 17, 2023
Sponsor: Theratocular Biotek Co.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Ocular Hypertension

Stress

Vascular Diseases

Treatment

Placebo

TO-O-1001

Clinical Study ID

NCT05456724
TO-01C101
  • Ages 18-59
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a Phase I/II stage to investigate the safety, tolerability, and ocular hypotensive efficacy of TO-O-1001 in healthy volunteers and patients with Open-Angle Glaucoma or Ocular Hypertension.

The proposed trial consists of 3 study parts to be conducted at Nucleus Network Melbourne.

This study will enroll up to 34 evaluable healthy volunteers in part 1(SAD) and part 2(MD) and 16 evaluable patients with Open-Angle Glaucoma or Ocular Hypertension in part 3(MD).

Note- As of 14Mar2023, enrolment has been completed for Part 1 and Part 2 and recruitment is pending now for Part 3.

Eligibility Criteria

Inclusion

Inclusion Criteria: For Healthy Subjects (Parts 1 & 2)

  1. 18 - 59-year-old healthy male or female subjects who are non-lactating andnon-pregnant.
  2. BMI 18.0~32.0(kg/m2) and body weight more than 45kg.
  3. Intraocular pressure between 10 - 21 mm Hg (inclusive) in each eye.
  4. Best-corrected visual acuity (BCVA) in each eye of 20/40 ETRDS or better.
  5. The informed consent form has been read, signed and dated by the subjects.
  6. Able to communicate well with the investigator and comply with the requirements of thestudy. For Patients (Part 3)
  7. Must be 18 years of age or older.
  8. Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT).
  9. Unmedicated or after washout intraocular pressure (IOP) >20 mmHg and < 30 mmHg instudy eye at T0 (T0 = 08:00AM~10:00 AM) of the first qualification visit (Day 1).
  10. Best-corrected visual acuity (BCVA) equivalent to 20/200 ETRDS or better.
  11. The informed consent form has been read, signed and dated by the subjects.
  12. Able to communicate well with the investigator and comply with the requirements of thestudy

Exclusion

Exclusion Criteria: For Healthy Subjects (Parts 1 & 2)

  1. Subjects has chronic or acute ophthalmic disease including glaucoma, maculardegeneration, and clinically significant cataract (primary or secondary).
  2. Subjects has previous glaucoma intraocular surgery or glaucoma laser procedures within 3 years.
  3. Subjects has refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) within 5years.
  4. Subjects has ocular trauma within the past 6 months, or ocular surgery or lasertreatment within the past three months (e.g., laser treatment for glaucoma or retina). For Patients (Part 3)
  5. Closed or very narrow angles (Grade 0-1) or those the investigator judges asoccludable and/or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degreesby gonioscopy within 6 months prior to Screening Visit in either eye. (Patent laseriridotomy with Grade 1-2 angles is acceptable in either eye, providing the PAScriteria are still met).
  6. Previous glaucoma intraocular surgery in either eye. Prior laser trabeculoplasty (ALTor SLT) in either eye is allowed if performed more than 6 months prior to ScreeningVisit.
  7. Any non-glaucoma intraocular surgery within 3 months prior to Screening Visit ineither eye.
  8. Participation in a clinical study with use of any investigational drug or treatmentwithin 28 days prior to Baseline (Day 1).
  9. Clinically significant abnormalities in: laboratory tests, physical examination, vitalsigns and/or ECG at Screening Visit. If in the investigator's judgment a subjects withclinically significant abnormalities is appropriate for enrollment in the study, adiscussion between the investigator and the Medical Monitor must occur and bedocumented prior to enrollment of this subjects in the study.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
August 04, 2022
Estimated Completion Date:
July 31, 2024

Connect with a study center

  • Nucleus Network Melbourne

    Melbourne, Victoria 3004
    Australia

    Site Not Available

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