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Could a common dry eye drop shield the Cornea's inner layer?

NCT ID NCT06329661

Disease control Sponsor: Novaliq GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests whether cyclosporine eye drops, a treatment for dry eye disease, can help maintain the health of corneal endothelial cells—the cells that keep the cornea clear. About 204 adults with dry eye will receive either cyclosporine drops or a saline solution for 12 months. Researchers will measure changes in corneal endothelial cell density to see if the treatment offers protective benefits.

What this could mean

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

Active substance
Cyclosporine ophthalmic solution, 0.1% (eye drops)
What this could lead to
If successful, this could show that cyclosporine eye drops help preserve the inner layer of the cornea in people with dry eye, potentially guiding better long-term eye care.
What could go wrong
This is a Phase 4 trial, so the drug is already approved, but the specific effect on corneal endothelial cells is not yet proven. Results may vary, and eye drops can cause irritation or other side effects.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

204 people

The number who actually took part.

Started

Apr 2024

Finished

Jul 2025

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: * Be at least 18 years of age; * Provide written informed consent; * Have a subject reported history of dry eye disease (DED) in both eyes * Be able and willing to follow instructions, including participation in all trial assessments and visits. Exclusion Criteria: * Be a woman who is pregnant, nursing, or planning a pregnancy; * Unwillingness to to use acceptable means of birth control * Clinically significant slit-lamp findings or abnormal lid anatomy at screening * Ongoing ocular or systemic infection at screening or baseline * Presence of uncontrolled systemic diseases * Presence of known allergy and/or sensitivity to the study drug or its components * Intraocular surgery or ocular laser surgery or significant trauma within 365 days before Visit 1, or have any planned ocular surgeries during the trial period * Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the trial results, or may interfere with the subject's participation in the trial significantly. * Randomized in a previous CyclASol trial

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

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

Dry eye disease Endothelial cell

Contacts and locations

Locations

  • CYS-007 Investigational Site

    Newport Beach, California, 92663, United States

  • CYS-007 Investigational Site

    Torrance, California, 90505, United States

  • CYS-007 Investigational Site

    Garner, North Carolina, 27529, United States

  • CYS-007 Investigational Site

    Shelby, North Carolina, 28150, United States

  • CYS-007 Investigational Site

    Cranberry Township, Pennsylvania, 16066, United States

  • CYS-007 Investigational Site

    Memphis, Tennessee, 38120, United States

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