Open Angle GlaucomaPhase 1/2NCT05456724
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
A Phase 1/2 study testing TO-O-1001 in people with Open Angle Glaucoma and Ocular Hypertension, run by Theratocular Biotek Co. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- TO-O-1001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Aug 2022to 31 Jul 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- TO-O-1001, Placebo
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TO-O-1001Drug
TO-O-1001 ophthalmic solution in two concentration (0.05% and 0.1%) ocular administration only one drop in one eye
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: TO-O-1001 |
| B (Placebo) | Placebo comparator | Dosage form: ophthalmic solution Route of administration: topical ocular Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of TO-O-1001 though the incidence of adverse events.
Number of participants with treatment-emergent adverse events (AEs).
Measured: Up to 28 days
Evaluate the ocular hypotensive efficacy of TO-O-1001 through Goldmann Applanation Tonometry.
The primary efficacy outcome is mean IOP.
Measured: Up to 28 days
Secondary outcomes (8)
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Parameter: Area Under the Curve (AUC)
Measured: Up to 8 days
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Parameter: Maximum Concentration
Measured: Up to 8 days
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Parameter: Maximum observed concentration (Cmax in first and last dose)
Measured: Up to 8 days
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)
Measured: Up to 8 days
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Parameter: Time of observed Cmax
Measured: Up to 8 days
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
Measured: Up to 8 days
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.
Measured: Up to 28 days
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.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start4 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theratocular Biotek Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Sam Francis, Principal investigator, Nucleus Network Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456724
- Sponsor's protocol ID
- TO-01C101
- Status last verified
- Oct 2023
- First submitted
- 27 Jun 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05456724
- Acronym / sponsor ID
- TO-01C101
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Theratocular Biotek Co.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (TO-O-1001) | Experimental | Drug: TO-O-1001Drug: TO-O-1001 Dose level: 0.05% and 0.1% Dosage form: ophthalmic solution Route of administration: topical ocular |
| B (Placebo) | Placebo comparator | Other: PlaceboDosage form: ophthalmic solution Route of administration: topical ocular |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TO-O-1001TO-O-1001 ophthalmic solution in two concentration (0.05% and 0.1%) ocular administration only one drop in one eye | Drug | A (TO-O-1001) |
| PlaceboThe 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 | Other | B (Placebo) |
Primary outcome
Safety and tolerability of TO-O-1001 though the incidence of adverse events.
Time frame: Up to 28 days
Number of participants with treatment-emergent adverse events (AEs).
Evaluate the ocular hypotensive efficacy of TO-O-1001 through Goldmann Applanation Tonometry.
Time frame: Up to 28 days
The primary efficacy outcome is mean IOP.
8 secondary outcomes
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Time frame: Up to 8 days
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Time frame: Up to 8 days
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Time frame: Up to 8 days
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Time frame: Up to 8 days
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Time frame: Up to 8 days
Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.
Time frame: Up to 8 days
Best Corrected Visual Acuity (BCVA) of TO-O-1001.
Time frame: Up to 28 days
Safety and tolerability of TO-O-1001 through the incidence, severity and causality of serious adverse events (SAEs).
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Francis principal investigator
Nucleus Network Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TO-O-1001 in people with Open Angle Glaucoma and Ocular Hypertension, run by Theratocular Biotek Co. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of TO-O-1001 though the incidence of adverse events. (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.