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New eye drop aims to soothe dry, irritated eyes

NCT ID NCT07625124

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an experimental eye drop called RCI001 in 200 adults with dry eye disease. Participants will use the drops or a placebo for 4 weeks. The goal is to see if RCI001 reduces eye discomfort and damage to the eye's surface better than placebo. The study is not yet recruiting.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

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

Expected to start

Sep 2027

An estimate. Start dates often move.

Expected to finish

Aug 2028

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. At least 18 years of age at the Screening Visit (Visit 1), of either gender and any race. 2. Able and willing to provide written informed consent. 3. Willing and able to comply with all study procedures. 4. Patient-reported history of dry eye for at least 6 months prior to Visit 1. 5. History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1. 6. Best corrected visual acuity (BCVA) of 0.7 logMAR or better (Snellen equivalent of 20/100 or better) in each eye at Visit 1. 7. At least one eye, the same eye, must satisfy all criteria for Schirmer's Test, corneal fluorescein staining, conjunctival lissamine green staining, conjunctival redness, and CAE response. 8. Female participants of childbearing potential must have a negative urine pregnancy test and must use adequate birth control throughout the study period. For non-sexually active females, abstinence may be regarded as an adequate method of birth control. Exclusion Criteria: 1. Clinically significant slit-lamp findings at Visit 1, including active blepharitis, meibomian gland dysfunction, severe lid margin inflammation, or active ocular allergies requiring therapeutic treatment, and/or findings that in the opinion of the investigator may interfere with study parameters. Participants with moderate to severe meibomian gland dysfunction, in the opinion of the investigator, are not eligible. 2. Ongoing ocular infection, including bacterial, viral, or fungal infection, or active ocular inflammation at Visit 1. 3. Contact lens wear within 7 days of Visit 1 or anticipated use of contact lenses during the study. 4. LASIK surgery within the last 12 months. 5. Female participant who is pregnant, nursing, or planning a pregnancy. 6. Female participant of childbearing potential who is unwilling to submit a urine pregnancy test at Visit 1 and Visit 4, or at an early termination visit. 7. Female participant of childbearing potential who is not using an acceptable method of birth control. Acceptable methods include hormonal contraceptives, mechanical contraception with spermicide and a barrier method, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as adequate; however, if the participant becomes sexually active during the study, she must agree to use adequate birth control for the remainder of the study. 8. Known allergy and/or sensitivity to the test article or its components. 9. Any condition or situation that, in the investigator's opinion, may put the participant at significant risk, may confound study results, or may interfere significantly with participation in the study. 10. Current enrollment in an investigational drug or device study or use of an investigational drug or device within 30 days of Visit 1. 11. Unable or unwilling to follow instructions, including participation in all study assessments and visits.

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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

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.