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

NCT ID: NCT05456724

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-04
• Study Completion Date: 2024-07-31

Brief 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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A (TO-O-1001)

Drug: TO-O-1001 Dose level: 0.05% and 0.1% Dosage form: ophthalmic solution Route of administration: topical ocular

Group Type: EXPERIMENTAL

TO-O-1001

Intervention Type: DRUG

TO-O-1001 ophthalmic solution in two concentration (0.05% and 0.1%) ocular administration only one drop in one eye

B (Placebo)

Dosage form: ophthalmic solution Route of administration: topical ocular

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo is of same visual appearance and identical formulation as TO-O-1001, except the active component TO-168 ocular administration only one drop in one eye

Interventions

TO-O-1001

TO-O-1001 ophthalmic solution in two concentration (0.05% and 0.1%) ocular administration only one drop in one eye

Intervention Type: DRUG

Placebo

The placebo is of same visual appearance and identical formulation as TO-O-1001, except the active component TO-168 ocular administration only one drop in one eye

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novotech (Australia) Pty Limited

INDUSTRY

Sponsor Role: collaborator

Theratocular Biotek Co.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Francis

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network Melbourne

Locations

Nucleus Network Melbourne

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

TO-01C101

Identifier Type: -

Identifier Source: org_study_id