Overview

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

Status:
Not yet recruiting
Trial end date:
2023-07-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Theratocular Biotek Co.
Collaborator:
Novotech (Australia) Pty Limited
Criteria
Inclusion Criteria:

For Healthy Subjects (Parts 1 & 2)

1. 18 - 59-year-old healthy male or female subjects who are non-lactating and
non-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 the
study.

For Patients (Part 3)

1. Must be 18 years of age or older.

2. Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT).

3. Unmedicated or after washout intraocular pressure (IOP) >20 mmHg and < 30 mmHg in
study eye at T0 (T0 = 08:00AM~10:00 AM) of the first qualification visit (Day 1).

4. Best-corrected visual acuity (BCVA) equivalent to 20/200 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 the
study

Exclusion Criteria:

For Healthy Subjects (Parts 1 & 2)

1. Subjects has chronic or acute ophthalmic disease including glaucoma, macular
degeneration, 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 5
years.

4. Subjects has ocular trauma within the past 6 months, or ocular surgery or laser
treatment within the past three months (e.g., laser treatment for glaucoma or retina).

For Patients (Part 3)

1. Closed or very narrow angles (Grade 0-1) or those the investigator judges as
occludable and/or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees
by gonioscopy within 6 months prior to Screening Visit in either eye. (Patent laser
iridotomy with Grade 1-2 angles is acceptable in either eye, providing the PAS
criteria are still met).

2. Previous glaucoma intraocular surgery in either eye. Prior laser trabeculoplasty (ALT
or SLT) in either eye is allowed if performed more than 6 months prior to Screening
Visit.

3. Any non-glaucoma intraocular surgery within 3 months prior to Screening Visit in
either eye.

4. Participation in a clinical study with use of any investigational drug or treatment
within 28 days prior to Baseline (Day 1).

5. Clinically significant abnormalities in: laboratory tests, physical examination, vital
signs and/or ECG at Screening Visit. If in the investigator's judgment a subjects with
clinically significant abnormalities is appropriate for enrollment in the study, a
discussion between the investigator and the Medical Monitor must occur and be
documented prior to enrollment of this subjects in the study.