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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05456724




Registration number
NCT05456724
Ethics application status
Date submitted
27/06/2022
Date registered
13/07/2022
Date last updated
19/10/2023

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] 0 0
TO-01C101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open Angle Glaucoma 0 0
Ocular Hypertension 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
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] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of TO-O-1001 though the incidence of adverse events.
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Evaluate the ocular hypotensive efficacy of TO-O-1001 through Goldmann Applanation Tonometry.
Timepoint [2] 0 0
Up to 28 days
Secondary outcome [1] 0 0
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Timepoint [1] 0 0
Up to 8 days
Secondary outcome [2] 0 0
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Timepoint [2] 0 0
Up to 8 days
Secondary outcome [3] 0 0
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Timepoint [3] 0 0
Up to 8 days
Secondary outcome [4] 0 0
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Timepoint [4] 0 0
Up to 8 days
Secondary outcome [5] 0 0
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Timepoint [5] 0 0
Up to 8 days
Secondary outcome [6] 0 0
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Timepoint [6] 0 0
Up to 8 days
Secondary outcome [7] 0 0
Best Corrected Visual Acuity (BCVA) of TO-O-1001.
Timepoint [7] 0 0
Up to 28 days
Secondary outcome [8] 0 0
Safety and tolerability of TO-O-1001 through the incidence, severity and causality of serious adverse events (SAEs).
Timepoint [8] 0 0
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/Phase 2
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] 0 0
Nucleus Network Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Theratocular Biotek Co.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

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/ct2/show/NCT05456724
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Francis
Address 0 0
Nucleus Network Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries