40 Participants NeededMy employer runs this trial

ABR2 Eye Drops for Dry Eye

(DRAGON Trial)

CS
US
Overseen ByUlli Stahl, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Pleryon Therapeutics (Hangzhou) Limited
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and ease of using new eye drops called ABR2, designed to provide temporary relief from dry eyes. In the first part, participants receive a single drop in one eye. In the second part, they use the drops up to four times a day for 28 days. This study suits individuals who frequently experience eye discomfort due to dryness and do not wear contact lenses during the trial period. As an unphased trial, participants contribute to early research and may potentially experience relief from dry eyes.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but if you are using any medications that might affect the study results, the investigator may ask you to stop.

Is there any evidence suggesting that ABR2 eye drops are likely to be safe?

Research has shown that ABR2 eye drops are under careful study to determine their safety and ease of use. In this study, participants will use the drops to assess their effectiveness for dry eyes. Although detailed safety information about ABR2 is not yet available, it is important to note that eye drops can sometimes be recalled due to manufacturing issues. This does not imply that ABR2 has such problems, but safety remains a top priority in any eye drop study. This trial aims to evaluate the short-term safety and comfort of using ABR2, with participants closely monitored for any side effects.12345

Why are researchers excited about this trial?

Most treatments for dry eye, like artificial tears and anti-inflammatory medications, focus on providing temporary relief or reducing inflammation. But ABR2 eye drops take a different approach by potentially repairing the eye’s surface and improving tear production. This innovative mechanism targets the root cause of dry eye rather than just alleviating symptoms. Researchers are excited about ABR2 because it could offer longer-lasting relief and improve overall eye health, which current options struggle to achieve.

What evidence suggests that ABR2 eye drops might be an effective treatment for dry eye?

Research has shown that eye drops similar to ABR2, such as those containing rebamipide, improve how long the eye remains moist compared to regular artificial tears. They help keep the eye surface wet for longer. Other treatments for dry eye, like those with dexpanthenol, have significantly reduced symptoms such as discomfort, dryness, and redness. These treatments have also enhanced tear quality and eye moisture, which is promising for ABR2. Although ABR2 is new, the positive outcomes from similar treatments suggest it could effectively relieve dry eye symptoms. Participants in this trial will receive ABR2 eye drops to assess their effectiveness in treating dry eye symptoms.678910

Who Is on the Research Team?

CL

Charis Lau, PharmD, OD

Principal Investigator

Pleryon Therapeutics

JW

Jill Woods, MSc, MCOptom

Principal Investigator

Centre for Ocular Research & Education, University of Waterloo

Are You a Good Fit for This Trial?

This trial is for people with dry eye symptoms who are seeking temporary relief. Participants should not have any major eye diseases or conditions that could interfere with the study, and must be able to follow instructions for using the eye drops.

Inclusion Criteria

Have signed an information and consent letter
I am at least 18 years old and able to make my own decisions.
Are able to read (Part 2 only)
See 4 more

Exclusion Criteria

Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days
I do not have any eye exam results that prevent me from using the study product.
I am not taking any medications that could affect the study results.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Part 1: 1 visit, Part 2: 1 visit
1 visit (in-person)

Treatment Part 1

Participants receive 1 drop of ABR2 in one eye with assessments over a 1-hour period

1 hour
1 visit (in-person)

Treatment Part 2

Participants use 1 drop of ABR2 at least two times a day for 28 days

28 days
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • ABR2

Trial Overview

The study tests a new lubricating eye drop called ABR2. In Part 1, participants get a single dose in one eye; in Part 2, they use the drops at least twice daily for 28 days. There is no comparison group—everyone receives ABR2.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2Experimental Treatment1 Intervention
Group II: Part 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pleryon Therapeutics (Hangzhou) Limited

Lead Sponsor

University of Waterloo School of Optometry and Vision Science

Collaborator

Trials
1
Recruited
150+

Citations

Safety and efficacy of rebamipide compared to artificial tears ...

Our study demonstrated RBM at both doses have greater improvements in TBUT than artificial tears. RBM may be considered as the first-line ...

Selective Pharmacologic Therapies for Dry Eye Disease ...

Across pivotal trials, treatment with OTX-101 was frequently reported to improve efficacy parameters at 4 weeks, including mean CFB in total CFS ...

Effects of Dry Eye Treatments on the Ocular Surface

This study evaluated the effects of the corticosteroid dexamethasone on suppressing development of eye irritation, cornea epithelial disease and increased ...

The role of Dex panthenol Eye Drops in Treating ...

(2023) noted significant improvements in dry eye symptoms, such as reduced discomfort, dryness, and redness. These improvements were associated with better tear ...

The efficacy of autologous serum eye drops for ... - IOVS

Conclusion:Autologous serum eye drop use was associated with improvement of clinical symptom and signs in KCS. This study provided evidence that autologous ...

Evaluation of a Novel Ocular Lubricating Eye Drop

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 ...

ABR2 Eye Drops for Dry Eye (DRAGON Trial)

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 ...

Several OTC Eye Drops Recalled Over Manufacturing ...

A voluntary recall has been issued for several over-the-counter eye drop products due to manufacturing issues that could affect their safety.

Potentially hazardous eye care products recalled nationwide

The FDA gave its second-highest warning rating (a Class II risk) to 5 ophthalmic solutions because of violations of current manufacturing ...

Eye Care Products Recalled Over Quality Risk, FDA Says

The products, which are used to relieve dry and irritated eyes, have been voluntarily recalled by BRS Analytical Service, a pharmaceutical ...