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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05456724

Registration number

NCT05456724

Ethics application status

Date submitted

27/06/2022

Date registered

13/07/2022

Titles & IDs

Public 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

Scientific 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

Secondary ID [1]

TO-01C101

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Open Angle Glaucoma

Ocular Hypertension

Condition category

Condition code

Eye

Diseases / disorders of the eye

Cardiovascular

Hypertension

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - TO-O-1001
Other interventions - Placebo

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

Placebo comparator: B (Placebo) - Dosage form: ophthalmic solution Route of administration: topical ocular

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

Other interventions: 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 code [1]

Treatment: Drugs

Intervention code [2]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

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

Timepoint [1]

Up to 28 days

Primary outcome [2]

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

Timepoint [2]

Up to 28 days

Secondary outcome [1]

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

Timepoint [1]

Up to 8 days

Secondary outcome [2]

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

Timepoint [2]

Up to 8 days

Secondary outcome [3]

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

Timepoint [3]

Up to 8 days

Secondary outcome [4]

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

Timepoint [4]

Up to 8 days

Secondary outcome [5]

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

Timepoint [5]

Up to 8 days

Secondary outcome [6]

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

Timepoint [6]

Up to 8 days

Secondary outcome [7]

Best Corrected Visual Acuity (BCVA) of TO-O-1001.

Timepoint [7]

Up to 28 days

Secondary outcome [8]

Safety and tolerability of TO-O-1001 through the incidence, severity and causality of serious adverse events (SAEs).

Timepoint [8]

Up to 28 days

Eligibility

Key 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

Minimum age

18 Years

Maximum age

59 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

4/08/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

31/07/2024

Actual

Sample size

Target

50

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Nucleus Network Melbourne - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Theratocular Biotek Co.

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

Novotech (Australia) Pty Limited

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT05456724

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Sam Francis

Address

Nucleus Network Melbourne

Country

Phone

Fax

Email

Contact person for public queries

Name

Address

Country

Phone

Fax

Email

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05456724