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New eye ointment for dry eye passes first safety check

NCT ID NCT07521748

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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 Results may not be published yet.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

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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This status has not been confirmed recently, so it may be out of date.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 early-stage study tests whether a new eye ointment called RC017 is safe and tolerable in 24 healthy adults aged 18 to 55. The ointment is being developed to treat dry eye disease. Participants will receive either the ointment or a placebo, and researchers will monitor for side effects and how the drug moves through the body.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 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 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Healthy male and female trial participants aged 18 to 55 years old (inclusive); 2. Body Mass Index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive), with body weight ≥ 50 kg for males and ≥ 45 kg for females; 3. At screening, best corrected visual acuity (BCVA) of both eyes should be ≥ 1.0; in addition, ophthalmic examinations (including assessment of ocular symptoms, slit-lamp microscopy/external eye examination, corneal fluorescein staining, funduscopy, and intraocular pressure measurement) should show no abnormalities in both eyes, or any abnormalities detected should be judged as clinically insignificant by the investigator; 4. Have a full understanding of the trial procedures, voluntarily participate in the trial, and sign a written informed consent form (ICF); 5. Female participants with childbearing potential must have a negative result in the serum pregnancy test at screening. Throughout the entire study period and within 3 months after the study conclusion, all female participants, male participants and their sexual partners must agree to adopt effective contraceptive measures (Note: Contraceptive measures include both pharmacological and non-pharmacological methods, see Appendix 4 for details). Exclusion Criteria: 1. History of ocular diseases deemed by the investigator as unsuitable for enrollment, including but not limited to dry eye, glaucoma, blepharitis, meibomianitis, allergic conjunctivitis, iritis, uveitis, and/or active ocular inflammation or infection. 2. Prior history of ocular surgeries, including laser refractive surgery and intraocular surgery, etc. 3. Participants who wore contact lenses or cosmetic colored contact lenses within 2 weeks prior to screening, or those requiring contact lens wear during the trial. 4. Use of any prescription or over-the-counter (OTC) medications (including vitamins, antacids, Chinese herbal medicines, dietary supplements, and topical ophthalmic drugs) within 2 weeks prior to screening. 5. Clinically significant abnormalities in vital signs, physical examination findings, laboratory test results (complete blood count \[CBC\], urine routine, blood biochemistry, coagulation function, infectious disease screening, serum pregnancy test \[females only\]) or 12-lead electrocardiogram (ECG), as judged by the investigator. 6. History of diseases involving the central nervous, mental, cardiovascular, renal, hepatic, respiratory, metabolic, or musculoskeletal systems, which in the investigator's judgment may compromise participant safety or interfere with study results. 7. Clinically significant history of allergies, especially drug allergies, or known hypersensitivity to any component of the study drug. 8. Daily cigarette smoking \> 5 sticks within 3 months prior to the trial. 9. Suspected or confirmed alcohol dependence; average daily alcohol intake \> 2 units within 3 months (1 unit = 10 mL pure ethanol, equivalent to 200 mL beer \[5% alcohol\], 25 mL spirits \[40% alcohol\], or 83 mL wine \[12% alcohol\]); or positive alcohol test result. 10. History of drug abuse; or positive urine test for ketamine, morphine, methamphetamine, MDMA, or tetrahydrocannabinol carboxylic acid (THC-COOH). 11. Participation in another clinical trial within 3 months prior to screening. 12. Blood donation or blood loss ≥ 400 mL within 3 months prior to screening. 13. Pregnant or lactating females. 14. Unsuitability for venous blood collection. 15. Vaccination within 30 days prior to screening, or planned vaccination during the study period. 16. Any other conditions deemed by the investigator as unsuitable for enrollment.

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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.

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