Dry Eye SyndromesPhase 2NCT06337981
Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients
A Phase 2 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) 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
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Nov 2021to 28 Nov 2022
- Phase
- Phase 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 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 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 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.
About this study
Official title: A Phase 2 Multicenter, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AJU-S56 in Patients With Dry Eye Disease
This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease.
- Conditions
- Dry Eye Syndromes
- Being tested
- (AJU-S56 5% and placebo), AJU-S56 5%, Placebo(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% and placebo)Drug
Also called Test 1 group(AJU-S56 5% and placebo, each 1 drop/1time, 3times in a day)
(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day
AJU-S56 5%Drug
Also called Test 2 group(AJU-S56 5%, 1 drop/1time, 6times in a day)
(AJU-S56 5%), 1drop/1times, 6times in a day
Placebo(Vehicle)Drug
Also called Placebo group(Vehicle, 1 drop/1time, 6times in a day)
Placebo(Vehicle), 1drop/1times, 6times in a day
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 | Experimental | (AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day Receives: Drug: (AJU-S56 5% and placebo) |
| Test group 2 | Experimental | (AJU-S56 5%), 1drop/1times, 6times in a day Receives: Drug: AJU-S56 5% |
| Comparator group | Placebo comparator | Placebo(Vehicle), 1drop/1times, 6times in a day Receives: Drug: Placebo(Vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total corneal staining score (TCSS)
Total corneal staining score (TCSS) ≥4 at baseline (Total Max score : 15, bigger socre means worse outcome)
Measured: WEEK 4(Visit 4) (*Baseline, Visit 2 is performed in Day 0, Week 0)
Secondary outcomes (2)
LGCSS
Lissamine Green Conjunctival Staining Score(Total score : 0~18)
Measured: WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)
TFBUT
Tear Film Break Up Time
Measured: WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start22 Nov 2021
- Primary completion14 Jun 2022
- Study completion28 Nov 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
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
- NCT06337981
- Sponsor's protocol ID
- 21DE20901
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 29 Apr 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AJU-S56 in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06337981
- Acronym / sponsor ID
- 21DE20901
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- GL Pharm Tech Corporation
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 29 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) 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Test group 1 | Experimental | Drug: (AJU-S56 5% and placebo)(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day |
| Test group 2 | Experimental | Drug: AJU-S56 5%(AJU-S56 5%), 1drop/1times, 6times in a day |
| Comparator group | Placebo comparator | Drug: Placebo(Vehicle)Placebo(Vehicle), 1drop/1times, 6times in a day |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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. TCSS (National eye institute (NEI) scale)≥ 4 Schirmer test(without anesthesia) ≤ 10mm in 5 mins Tear break-up time ≤ 6 secs
- Written informed consent to participate in the trial
Key exclusion criteria (4 listed)
- Those who have clinically significant eye disease not related to dry eye syndrome
- 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% and placebo)Also: Test 1 group(AJU-S56 5% and placebo, each 1 drop/1time, 3times in a day)(AJU-S56 5%) and placebo(Vehicle), 1drop/1times, 3times in a day | Drug | Test group 1 |
| AJU-S56 5%Also: Test 2 group(AJU-S56 5%, 1 drop/1time, 6times in a day)(AJU-S56 5%), 1drop/1times, 6times in a day | Drug | Test group 2 |
| Placebo(Vehicle)Also: Placebo group(Vehicle, 1 drop/1time, 6times in a day)Placebo(Vehicle), 1drop/1times, 6times in a day | Drug | Comparator group |
Primary outcome
Total corneal staining score (TCSS)
Time frame: WEEK 4(Visit 4) (*Baseline, Visit 2 is performed in Day 0, Week 0)
Total corneal staining score (TCSS) ≥4 at baseline (Total Max score : 15, bigger socre means worse outcome)
2 secondary outcomes
LGCSS
Time frame: WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)
TFBUT
Time frame: WEEK 2(Visit 3), 4(Visit 4), 8(Visit 5), 12(Visit 12) (*Baseline, Visit 2 is performed in Day 0, Week 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 4 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: finished, as of the sponsor's last update on 29 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total corneal staining score (TCSS) (time frame: WEEK 4(Visit 4) (*Baseline, Visit 2 is performed in Day 0, Week 0)). 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 29 Apr 2024.