New eye ointment for dry eye passes first safety check
NCT ID NCT07521748
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
Only the study team decides who joins. These are the ways to reach them.
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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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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.
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Other studies related to the condition(s) this trial covers.
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