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

NCT05456724 | Unknown Phase 1 DMC

• 1 other identifier: TO-01C101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of TO-O-1001 though the incidence of adverse events.

  Number of participants with treatment-emergent adverse events (AEs).

  Up to 28 days

• Evaluate the ocular hypotensive efficacy of TO-O-1001 through Goldmann Applanation Tonometry.

  The primary efficacy outcome is mean IOP.

  Up to 28 days

Secondary Outcomes (8)

• Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.

  Up to 8 days

• Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.

  Up to 8 days

• Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.

  Up to 8 days

• Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.

  Up to 8 days

• Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.

  Up to 8 days

Study Arms (2)

A (TO-O-1001)

EXPERIMENTAL

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

Drug: TO-O-1001

B (Placebo)

PLACEBO COMPARATOR

Dosage form: ophthalmic solution Route of administration: topical ocular

Other: Placebo

Interventions

TO-O-1001 DRUG

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

A (TO-O-1001)

Placebo 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

B (Placebo)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For Healthy Subjects (Parts 1 \& 2)
• year-old healthy male or female subjects who are non-lactating and non-pregnant.
• BMI 18.0\~32.0(kg/m2) and body weight more than 45kg.
• Intraocular pressure between 10 - 21 mm Hg (inclusive) in each eye.
• Best-corrected visual acuity (BCVA) in each eye of 20/40 ETRDS or better.
• The informed consent form has been read, signed and dated by the subjects.
• Able to communicate well with the investigator and comply with the requirements of the study.
• For Patients (Part 3)
• Must be 18 years of age or older.
• Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT).
• 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).
• Best-corrected visual acuity (BCVA) equivalent to 20/200 ETRDS or better.
• The informed consent form has been read, signed and dated by the subjects.
• Able to communicate well with the investigator and comply with the requirements of the study

You may not qualify if:

• For Healthy Subjects (Parts 1 \& 2)
• Subjects has chronic or acute ophthalmic disease including glaucoma, macular degeneration, and clinically significant cataract (primary or secondary).
• Subjects has previous glaucoma intraocular surgery or glaucoma laser procedures within 3 years.
• Subjects has refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) within 5 years.
• 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)
• 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).
• 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.
• Any non-glaucoma intraocular surgery within 3 months prior to Screening Visit in either eye.
• Participation in a clinical study with use of any investigational drug or treatment within 28 days prior to Baseline (Day 1).
• 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.

Sponsors & Collaborators

• Theratocular Biotek Co.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Nucleus Network Melbourne

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Sam Francis

  Nucleus Network Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 13, 2022
• Study Start: August 4, 2022
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)