Dry Eye SyndromesPhase 3NCT06291194
Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients
A Phase 3 study testing AJU-S56 5% in people with Dry Eye Syndromes, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial summary
This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- AJU-S56 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Nov 2023to May 2024
- Phase
- Phase 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female who over 19 years old
- Moderate to Severe Dry Eye Disease Patients
- Must meet all criteria listed below at least in one eye or both eyes.
- TCSS (National eye institute (NEI) scale)≥ 4
- Ocular discomfort score (ODS) ≥ 3
- Schirmer test(without anesthesia) ≤ 10mm in 5 mins
- Tear break-up time ≤ 6 secs
- Written informed consent to participate in the trial
Who cannot join
- Those who have clinically significant eye disease not related to dry eye syndrome
- Those who have worn contact lenses before 1week Screening visit or have to wear contact lenses or need to wear contact lenses during study period
- Those who have medical history with intraocular surgery 12months before screening visit
- Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
- Participation in other studies within 4weeks of screening visit
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
AJU Pharm Co., Ltd.
Seoul
JUNGMIN LEE, +82-02-2630-0700, ajuf13001@ajupharm.co.kr
About this study
Official title: The Purpose of This Clinical Study is to Prove That the Test Drug (AJU-S56 5%) is Superior to the Control Drug After 24 Weeks of Administration to Patients Who Have Moderate or Severe Dry Eye Syndrome
This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.
- Conditions
- Dry Eye Syndromes
- Being tested
- AJU-S56 5%, Placebo Group(Vehicle)
- Keywords
- Dry eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJU-S56 5%Drug
Also called Test Group
After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).
Placebo Group(Vehicle)Drug
Also called Control Group
After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).
| Study group | Role | What they receive |
|---|---|---|
| Test group(AJU-S56 5%) | Experimental | QID(4 times in a day) for 24 Weeks after Randomization Receives: Drug: AJU-S56 5% |
| Placebo group(Vehicle) | Placebo comparator | QID(4 times in a day) for 24 Weeks after Randomization Receives: Drug: Placebo Group(Vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total corneal staining score (TCSS)
TCSS ≥4 at baseline (Total Max score : 15)
Measured: WEEK 4, 8, 12
Secondary outcomes (2)
LGCSS
Lissamine Green Conjunctival Staining Score(Total score : 0~18)
Measured: WEEK 4, 8, 12
TFBUT
Tear Film Break Up Time
Measured: WEEK 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start10 Nov 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AJU Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GL Pharm Tech Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291194
- Sponsor's protocol ID
- 22DE30902
- Status last verified
- Apr 2024
- First submitted
- 27 Feb 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Purpose of This Clinical Study is to Prove That the Test Drug (AJU-S56 5%) is Superior to the Control Drug After 24 Weeks of Administration to Patients Who Have Moderate or Severe Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT06291194
- Acronym / sponsor ID
- 22DE30902
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- GL Pharm Tech Corporation
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 4 Mar 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 study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.
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 |
|---|---|---|
| Test group(AJU-S56 5%) | Experimental | Drug: AJU-S56 5%QID(4 times in a day) for 24 Weeks after Randomization |
| Placebo group(Vehicle) | Placebo comparator | Drug: Placebo Group(Vehicle)QID(4 times in a day) for 24 Weeks after Randomization |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and Female who over 19 years old
- Moderate to Severe Dry Eye Disease Patients
- Must meet all criteria listed below at least in one eye or both eyes.
- Written informed consent to participate in the trial
Key exclusion criteria (5 listed)
- Those who have clinically significant eye disease not related to dry eye syndrome
- Those who have worn contact lenses before 1week Screening visit or have to wear contact lenses or need to wear contact lenses during study period
- Those who have medical history with intraocular surgery 12months before screening visit
- Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
- Participation in other studies within 4weeks of screening visit
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 |
|---|---|---|
| AJU-S56 5%Also: Test GroupAfter Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24). | Drug | Test group(AJU-S56 5%) |
| Placebo Group(Vehicle)Also: Control GroupAfter Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24). | Drug | Placebo group(Vehicle) |
Primary outcome
Total corneal staining score (TCSS)
Time frame: WEEK 4, 8, 12
TCSS ≥4 at baseline (Total Max score : 15)
2 secondary outcomes
LGCSS
Time frame: WEEK 4, 8, 12
TFBUT
Time frame: WEEK 4, 8, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AJU-S56 5% in people with Dry Eye Syndromes, run by AJU Pharm 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 8 inclusion and 5 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 8 Apr 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. 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 phase mean?
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 JUNNGMIN LEE (+82-02-2630-0700, ajuf13001@ajupharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total corneal staining score (TCSS) (time frame: WEEK 4, 8, 12). 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 8 Apr 2024.