Pupillary Dilation Effect During Cycloplegic RefractionPhase 2/3NCT06609525
Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects
A Phase 2/3 study testing CTO0303-A, CTO0303-B and CTO0303-C in people with Pupillary Dilation Effect During Cycloplegic Refraction, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a prospective randomized study compared with active control arm. Read more about this study
- Who is it for?
- Ages 4 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pupillary Dilation Effect During Cycloplegic Refraction
- What is being tested?
- CTO0303-A, CTO0303-B and CTO0303-C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2024to 1 Mar 2025
- Phase
- Phase 2/3
- 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 4 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric or adolescent subjects those who get a written consent both whom and their parents (or legally acceptable representative)
- Pediatric or adolescent subjects aged 4 to 15 years old based on date of written consent
Who cannot join
- Subjects with a history of severe systemic reaction or increased sensitivity to atropine
- Subjects with anterior segment disease that interferes with ophthalmological examination (ex. corneal scar, corneal opacity and others)
- Subjects administered mydriatic medication within 14 days prior to administration of Investigational Product
- Subjects with contact lens
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Hyejeong Paik, MD
About this study
Official title: A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferior, Phase Ⅱb/Ⅲ Study to Evaluate the Safety and Efficacy of CTO0303
This is a prospective randomized study compared with active control arm.
Read the detailed description
This is a prospective randomized study compared with active control arm. The investigators compare the pupil size in subject when 30 minutes after administering IP (CTO0303 or active control).
- Being tested
- CTO0303-A, CTO0303-B, CTO0303-C
- Keywords
- pupillary dilation
- Medical subject headings
- Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO0303-ADrug
eye drop, 1 drop 3 times (every 5 minutes) a day
CTO0303-BDrug
eye drop, 1 drop 3 times (every 5 minutes) a day
CTO0303-CDrug
eye drop, 1 drop 3 times (every 5 minutes) a day
| Study group | Role | What they receive |
|---|---|---|
| CTO0303-A | Experimental | Not described Receives: Drug: CTO0303-A |
| CTO0303-B | Experimental | Not described Receives: Drug: CTO0303-B |
| CTO0303-C | Active comparator | Not described Receives: Drug: CTO0303-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupillary dilation effect at 30 minutes after administration
The pupil size is measured using a pupillometer 30 minutes after IP administration
Measured: From enrollment to the end of treatment at 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start9 May 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pupillary Dilation Effect During Cycloplegic RefractionStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609525
- Sponsor's protocol ID
- CTO0303
- Status last verified
- Jan 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferior, Phase Ⅱb/Ⅲ Study to Evaluate the Safety and Efficacy of CTO0303
- ClinicalTrials.gov ID
- NCT06609525
- Acronym / sponsor ID
- CTO0303
- Keywords
- pupillary dilation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 24 Sep 2024 (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 prospective randomized study compared with active control arm.
Detailed description
This is a prospective randomized study compared with active control arm. The investigators compare the pupil size in subject when 30 minutes after administering IP (CTO0303 or active control).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CTO0303-A | Experimental | Drug: CTO0303-A |
| CTO0303-B | Experimental | Drug: CTO0303-B |
| CTO0303-C | Active comparator | Drug: CTO0303-C |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric or adolescent subjects those who get a written consent both whom and their parents (or legally acceptable representative)
- Pediatric or adolescent subjects aged 4 to 15 years old based on date of written consent
Key exclusion criteria (4 listed)
- Subjects with a history of severe systemic reaction or increased sensitivity to atropine
- Subjects with anterior segment disease that interferes with ophthalmological examination (ex. corneal scar, corneal opacity and others)
- Subjects administered mydriatic medication within 14 days prior to administration of Investigational Product
- Subjects with contact lens
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 |
|---|---|---|
| CTO0303-Aeye drop, 1 drop 3 times (every 5 minutes) a day | Drug | CTO0303-A |
| CTO0303-Beye drop, 1 drop 3 times (every 5 minutes) a day | Drug | CTO0303-B |
| CTO0303-Ceye drop, 1 drop 3 times (every 5 minutes) a day | Drug | CTO0303-C |
Primary outcome
pupillary dilation effect at 30 minutes after administration
Time frame: From enrollment to the end of treatment at 1 day.
The pupil size is measured using a pupillometer 30 minutes after IP administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CTO0303-A, CTO0303-B and CTO0303-C in people with Pupillary Dilation Effect During Cycloplegic Refraction, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 2 inclusion and 4 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 24 Sep 2024. 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 South Korea. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Sukyoung Kwon, MPH., PhD (+82-799-0175, skkwon@taejoon.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pupillary dilation effect at 30 minutes after administration (time frame: From enrollment to the end of treatment at 1 day.). 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 24 Sep 2024.