New eye drops aim to soothe dry eyes – first human test underway
NCT ID NCT07640867
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests whether RCI001 eye drops are safe and tolerable in 40 healthy adult men. Participants receive either the active eye drops or a placebo, and researchers monitor for side effects and how the drug behaves in the body. This is a first step toward possibly developing a new treatment for dry eye.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RCI001 eye drops 0.25%
- What this could lead to
- If safe and well-tolerated, this could lead to further studies testing RCI001 as a treatment for dry eye symptoms.
- What could go wrong
- This is a very early Phase 1 trial in only 40 healthy men, not people with dry eye. It only tests safety and how the drug moves through the body, not whether it works for dry eye. Many drugs fail in later stages.
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
-
40 people
The number who actually took part.
- Started
-
Oct 2024
- Finished
-
Sep 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
-
19 to 50 years
- Sex
-
Male participants only
- Healthy volunteers
-
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 adult male volunteers aged 19 to 50 years at screening. 2. Body weight of 50.0 kg to 90.0 kg and body mass index (BMI) of 18.5 kg/m2 to 29.9 kg/m2 at screening. 3. Participants who have received sufficient explanation about the study, fully understand the study, voluntarily decide to participate, and provide written informed consent to comply with study requirements. 4. Participants who are considered eligible for this study by the investigator based on physical examination, clinical laboratory tests, medical interview, and other screening assessments. Exclusion Criteria: 1. Participants with a current or past history of clinically significant disease in the hepatobiliary system, kidney, nervous system, immune system, respiratory system, gastrointestinal system, endocrine system, hematologic or oncologic system, cardiovascular system, urinary system, or psychiatric system, including but not limited to severe hepatic impairment, viral hepatitis, severe renal impairment, heart failure, Torsade de pointes, mood disorder, or obsessive-compulsive disorder. 2. Participation in another clinical trial, including a bioequivalence study, and administration of an investigational product within 6 months before the first planned administration of the investigational product. 3. Current smoker who cannot stop smoking during the study period. Participants who stopped smoking at least 3 months before the first planned administration of the investigational product may be eligible. 4. Consumption of grapefruit, grapefruit juice, or grapefruit-containing foods from 3 days before the first planned administration of the investigational product until the end of the study, or inability to abstain from grapefruit-containing foods and beverages during this period. 5. Participants who are considered unsuitable for participation in the study by the investigator for any other reason.
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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.
Contacts and locations
Locations
-
Seoul national unversity hospital
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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