Dry Eye Syndrome (DES)DRAGONNCT07593404
Evaluation of a Novel Ocular Lubricating Eye Drop
A study testing Part 2 ABR2 At least twice a day for 28 days and Part 1: ABR2 single dose in one eye in people with Dry Eye Syndrome (DES), run by Pleryon Therapeutics (Hangzhou) Limited at 1 site in Canada.
Trial summary
The objective of this 2-part study is to assess the safety and tolerability of the new ocular lubricating drop ABR2 during short-term use in subjects for the temporary relief of ocular discomfort due to dryness of the eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome (DES)
- What is being tested?
- Part 2 ABR2 At least twice a day for 28 days and Part 1: ABR2 single dose in one eye
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are at least 18 years of age and have capacity to volunteer
- Are able to read (Part 2 only);
- Have signed an information and consent letter;
- Are willing to follow instructions and maintain the appointment schedule;
- Are willing to refrain from contact lens wear throughout the study period;
- Have a best corrected visual acuity of +0.20 LogMAR or better in each eye;
- Have an OSDI score ≥13 AND at least one of the following signs in at least one eye: Non-invasive tear film break-up time (NITBUT) < 10 sec, AND/OR ocular surface staining (> 5 corneal spots, and/ or > 9 conjunctival spots)
Who cannot join
- Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days;
- Have a known active ocular disease and/ or infection with the exception of dry eye disease;
- Have any slit lamp findings that would contraindicate use of the study product;
- Have a systemic condition that would contraindicate use of the study product;
- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Have undergone refractive error surgery or intraocular surgery within the last 12 months;
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- Have any known sensitivity or allergy to the diagnostic sodium fluorescein or to any ingredients in the study product;
- Are using ocular lubricating eye drops more than twice per day on a typical day over the past month (Part 2 only);
- Are an employee of the Centre for Ocular Research \& Education directly involved in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Ocular Research & Education, School of Optometry & Vision Science, University of Waterloo
Waterloo, Ontario, N2L 3G1
CORE Studies, 519-888-4742, corestudies@uwaterloo.ca
Ulli Stahl, PhD, 519-888-4742, ustahl@uwaterloo.ca
About this study
The objective of this 2-part study is to assess the safety and tolerability of the new ocular lubricating drop ABR2 during short-term use in subjects for the temporary relief of ocular discomfort due to dryness of the eye.
In Part 1, participant will receive 1 drop of ABR2 in one eye and through assessments over a 1-hour period.
In Part 2, participant will use 1 drop of ABR2 at least two times a day for 28-day period (may use up to 4 times a day as needed) This is a single arm, open label study with no placebo or comparative arm.
Read the detailed description
Part 1 has a total of 2 scheduled visits, including Screening and Treatment visit. Participants will attend Part 1 for a total of 3.0 hours.
Part 2 has a total of 6 scheduled visits, including the Screening, baseline \& dispense visit, day 3, 1-week, 2-week, and 4-week Follow Up. Participants will attend Part 2 for a total of 6.5 hours.
- Conditions
- Dry Eye Syndrome (DES)
- Being tested
- Part 2 ABR2 At least twice a day for 28 days, Part 1: ABR2 single dose in one eye
- Keywords
- dry eye syndrome, ophthalmic solution, lubrication
- 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.
Part 2 ABR2 At least twice a day for 28 daysDrug
Use ABR2 at least BID, up to QID for 28 days
Part 1: ABR2 single dose in one eyeDrug
Receive a single dose in one eye only
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Part 1 Participants Receives: Drug: Part 1: ABR2 single dose in one eye |
| Part 2 | Experimental | Part 2 Participants Receives: Drug: Part 2 ABR2 At least twice a day for 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Number of adverse events associated with the use of ocular eye drop. Example of adverse events may include, severe conjunctival and palpebral hyperemia, hypersensitivity, allergic reaction, eyelid edema, and photophobia.
Measured: At the end of Part 1: 60 minutes after single drop monocular instillation and At the end of Part 2 (after 28 days of bilateral use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Syndrome (DES)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pleryon Therapeutics (Hangzhou) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
- Investigators
- Charis Lau, PharmD, OD, Study chair, Pleryon TherapeuticsJill Woods, MSc, MCOptom, Principal investigator, Centre for Ocular Research & Education, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593404
- Sponsor's protocol ID
- PN251
- Other IDs
- P/892/25/PL
- Acronym
- DRAGON
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Small sample size re-identification risk and limited infrastructure for external data access.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Ocular Lubricating Eye Drop
- ClinicalTrials.gov ID
- NCT07593404
- Acronym / sponsor ID
- DRAGON / PN251
- Conditions
- Dry Eye Syndrome (DES)
- Keywords
- dry eye syndrome, ophthalmic solution, lubrication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pleryon Therapeutics (Hangzhou) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 May 2026 (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.
The objective of this 2-part study is to assess the safety and tolerability of the new ocular lubricating drop ABR2 during short-term use in subjects for the temporary relief of ocular discomfort due to dryness of the eye.
In Part 1, participant will receive 1 drop of ABR2 in one eye and through assessments over a 1-hour period.
In Part 2, participant will use 1 drop of ABR2 at least two times a day for 28-day period (may use up to 4 times a day as needed) This is a single arm, open label study with no placebo or comparative arm.
Detailed description
Part 1 has a total of 2 scheduled visits, including Screening and Treatment visit. Participants will attend Part 1 for a total of 3.0 hours.
Part 2 has a total of 6 scheduled visits, including the Screening, baseline \& dispense visit, day 3, 1-week, 2-week, and 4-week Follow Up. Participants will attend Part 2 for a total of 6.5 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Part 1: ABR2 single dose in one eyePart 1 Participants |
| Part 2 | Experimental | Drug: Part 2 ABR2 At least twice a day for 28 daysPart 2 Participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are at least 18 years of age and have capacity to volunteer
- Are able to read (Part 2 only);
- Have signed an information and consent letter;
- Are willing to follow instructions and maintain the appointment schedule;
- Are willing to refrain from contact lens wear throughout the study period;
Key exclusion criteria (9 listed)
- Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days;
- Have a known active ocular disease and/ or infection with the exception of dry eye disease;
- Have any slit lamp findings that would contraindicate use of the study product;
- Have a systemic condition that would contraindicate use of the study product;
- Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
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 |
|---|---|---|
| Part 2 ABR2 At least twice a day for 28 daysUse ABR2 at least BID, up to QID for 28 days | Drug | Part 2 |
| Part 1: ABR2 single dose in one eyeReceive a single dose in one eye only | Drug | Part 1 |
Primary outcome
Number of Adverse Events
Time frame: At the end of Part 1: 60 minutes after single drop monocular instillation and At the end of Part 2 (after 28 days of bilateral use)
Number of adverse events associated with the use of ocular eye drop. Example of adverse events may include, severe conjunctival and palpebral hyperemia, hypersensitivity, allergic reaction, eyelid edema, and photophobia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Small sample size re-identification risk and limited infrastructure for external data access.
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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.
Charis Lau, PharmD, OD study chair
Pleryon Therapeutics
Jill Woods, MSc, MCOptom principal investigator
Centre for Ocular Research & Education, University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Part 2 ABR2 At least twice a day for 28 days and Part 1: ABR2 single dose in one eye in people with Dry Eye Syndrome (DES), run by Pleryon Therapeutics (Hangzhou) Limited at 1 site in Canada.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 19 May 2026. 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 Canada. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CORE Studies (519-888-4742, corestudies@uwaterloo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: At the end of Part 1: 60 minutes after single drop monocular instillation and At the end of Part 2 (after 28 days of bilateral use)). 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 May 2026.