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New eye drop for dry eyes enters safety testing

NCT ID NCT07593404

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new lubricating eye drop called ABR2 in 40 adults with dry eye syndrome. The goal is to check if the drop is safe and tolerable when used for up to 28 days. Participants first receive a single drop in one eye, then use the drop at least twice daily for a month. This is an early-stage trial with no comparison group, so it focuses on side effects rather than effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABR2 (ocular lubricating eye drop)
What this could lead to
If successful, this could lead to a new over-the-counter option for temporary dry eye relief.
What could go wrong
This is a very early, small safety study with no placebo group, so it cannot prove the drop works better than existing products. Side effects like eye redness or allergy are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Are at least 18 years of age and have capacity to volunteer 2. Are able to read (Part 2 only); 3. Have signed an information and consent letter; 4. Are willing to follow instructions and maintain the appointment schedule; 5. Are willing to refrain from contact lens wear throughout the study period; 6. Have a best corrected visual acuity of +0.20 LogMAR or better in each eye; 7. 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) Exclusion Criteria: 1. Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days; 2. Have a known active ocular disease and/ or infection with the exception of dry eye disease; 3. Have any slit lamp findings that would contraindicate use of the study product; 4. Have a systemic condition that would contraindicate use of the study product; 5. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 6. Have undergone refractive error surgery or intraocular surgery within the last 12 months; 7. Have any known sensitivity or allergy to the diagnostic sodium fluorescein or to any ingredients in the study product; 8. Are using ocular lubricating eye drops more than twice per day on a typical day over the past month (Part 2 only); 9. Are an employee of the Centre for Ocular Research \& Education directly involved in this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre for Ocular Research & Education, School of Optometry & Vision Science, University of Waterloo

    RECRUITING

    Waterloo, Ontario, N2L 3G1, Canada

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