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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

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Active
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
TO-O-1001
Placebo
Sponsored by
Theratocular Biotek Co.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nucleus Network Melbourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A (TO-O-1001)

B (Placebo)

Arm Description

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

Dosage form: ophthalmic solution Route of administration: topical ocular

Outcomes

Primary Outcome Measures

Safety and tolerability of TO-O-1001 though the incidence of adverse events.
Number of participants with treatment-emergent adverse events (AEs).
Evaluate the ocular hypotensive efficacy of TO-O-1001 through Goldmann Applanation Tonometry.
The primary efficacy outcome is mean IOP.

Secondary Outcome Measures

Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Parameter: Area Under the Curve (AUC)
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Parameter: Maximum Concentration
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Parameter: Maximum observed concentration (Cmax in first and last dose)
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Parameter: Area under the concentration-time curve (AUC0-t and AUC0-inf in first and last dose)
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Parameter: Time of observed Cmax
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Parameter: Terminal elimination half-life and elimination constant in first and last dose
Best Corrected Visual Acuity (BCVA) of TO-O-1001.
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Safety and tolerability of TO-O-1001 through the incidence, severity and causality of serious adverse events (SAEs).
Number of participants with treatment-emergent serious adverse events.

Full Information

First Posted
June 27, 2022
Last Updated
October 17, 2023
Sponsor
Theratocular Biotek Co.
Collaborators
Novotech (Australia) Pty Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05456724
Brief Title
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
Official Title
A 3-Part, First-in-human, Double-Blind, Randomized, and Placebo-Controlled Study Assessing the Safety, Tolerability, and Efficacy of TO-O-1001 Ophthalmic Solution in Healthy Subjects and in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theratocular Biotek Co.
Collaborators
Novotech (Australia) Pty Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A (TO-O-1001)
Arm Type
Experimental
Arm Description
Drug: TO-O-1001 Dose level: 0.05% and 0.1% Dosage form: ophthalmic solution Route of administration: topical ocular
Arm Title
B (Placebo)
Arm Type
Placebo Comparator
Arm Description
Dosage form: ophthalmic solution Route of administration: topical ocular
Intervention Type
Drug
Intervention Name(s)
TO-O-1001
Intervention Description
TO-O-1001 ophthalmic solution in two concentration (0.05% and 0.1%) ocular administration only one drop in one eye
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety and tolerability of TO-O-1001 though the incidence of adverse events.
Description
Number of participants with treatment-emergent adverse events (AEs).
Time Frame
Up to 28 days
Title
Evaluate the ocular hypotensive efficacy of TO-O-1001 through Goldmann Applanation Tonometry.
Description
The primary efficacy outcome is mean IOP.
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Description
Parameter: Area Under the Curve (AUC)
Time Frame
Up to 8 days
Title
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Description
Parameter: Maximum Concentration
Time Frame
Up to 8 days
Title
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Description
Parameter: Maximum observed concentration (Cmax in first and last dose)
Time Frame
Up to 8 days
Title
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Description
Parameter: Area under the concentration-time curve (AUC0-t and AUC0-inf in first and last dose)
Time Frame
Up to 8 days
Title
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Description
Parameter: Time of observed Cmax
Time Frame
Up to 8 days
Title
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Description
Parameter: Terminal elimination half-life and elimination constant in first and last dose
Time Frame
Up to 8 days
Title
Best Corrected Visual Acuity (BCVA) of TO-O-1001.
Description
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Time Frame
Up to 28 days
Title
Safety and tolerability of TO-O-1001 through the incidence, severity and causality of serious adverse events (SAEs).
Description
Number of participants with treatment-emergent serious adverse events.
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For Healthy Subjects (Parts 1 & 2) 18 - 59-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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Francis
Organizational Affiliation
Nucleus Network Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nucleus Network Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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