Dry EyePhase 1NCT07640867

RCI001 Eye Drops 0.25% in Healthy Adult Male Participants

A Phase 1 study testing RCI001 Eye Drops 0.25% in people with Dry Eye, run by Rudacure at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is being conducted to evaluate the safety, tolerability, and pharmacokinetics of RCI001 eye drops 0.25% in healthy adult male participants. Pharmacokinetics means how the study drug is absorbed, distributed, and eliminated from the body over time. Read more about this study

Who is it for?: Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Dry Eye
What is being tested?: RCI001 Eye Drops 0.25%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteSouth Korea
Study dates: 28 Oct 2024to 20 Sep 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male volunteers aged 19 to 50 years at screening.
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.
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.
Participants who are considered eligible for this study by the investigator based on physical examination, clinical laboratory tests, medical interview, and other screening assessments.

Who cannot join

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.
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.
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.
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.
Participants who are considered unsuitable for participation in the study by the investigator for any other reason.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul national unversity hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Administration Phase 1 Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of RCI001 Eye Drops 0.25% in Healthy Male Subjects

Participants who meet the study requirements will be randomly assigned to receive either RCI001 eye drops 0.25% or placebo eye drops. The study treatment will be administered to the left eye according to the assigned dosing schedule. The study includes single-dose administration schedules and multiple-dose administration schedules for up to 15 days.

The study will monitor safety and tolerability through adverse event assessments, vital signs, physical examinations, electrocardiograms, laboratory tests, eye symptom assessments, and ophthalmic examinations. Blood samples will be collected at scheduled time points to measure the concentration of RCI001 in the blood.

Approximately 40 healthy adult male participants are planned to take part in this study.

Conditions: Dry Eye
Being tested: RCI001 Eye Drops 0.25%, Placebo Eye Drops
Keywords: RCI001 Eye Drops, Dry Eye Diseases, Phase 1 Clinical Trial, Rudacure
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RCI001 Eye Drops 0.25%Drug
Also called RCI001
RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.
Placebo Eye DropsDrug
Also called Matching placebo
Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.

Study groups in NCT07640867
Study group	Role	What they receive
RCI001 Eye Drops 0.25%, Single-Day Administration, Once Daily	Experimental	Not described Receives: Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Single-Day Administration, Once Daily	Placebo comparator	Not described Receives: Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Daily	Experimental	Not described Receives: Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Single-Day Administration, Twice Daily	Placebo comparator	Not described Receives: Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Daily	Experimental	Not described Receives: Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Single-Day Administration, Four Times Daily	Placebo comparator	Not described Receives: Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Multiple-Day Administration, Twice Daily	Experimental	Not described Receives: Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Multiple-Day Administration, Twice Daily	Placebo comparator	Not described Receives: Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Multiple-Day Administration, Four Times Daily	Experimental	Not described Receives: Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Multiple-Day Administration, Four Times Daily	Placebo comparator	Not described Receives: Drug: Placebo Eye Drops

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
The number and percentage of participants with adverse events will be summarized by treatment group. Adverse events will be assessed for seriousness, severity, relationship to the study drug, action taken, outcome, and whether they are treatment-emergent adverse events.
Measured: From informed consent through the post-study visit, up to Day 18 for single-administration cohorts and up to Day 32 for multiple-administration cohorts
Number of Participants With Clinically Significant Abnormalities in Safety Assessments
Safety assessments will include vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, ocular symptom assessments, and ophthalmic examinations. Clinically significant abnormalities will be summarized by treatment group.
Measured: From baseline through the post-study visit, up to Day 18 for single-administration cohorts and up to Day 32 for multiple-administration cohorts

Secondary outcomes (17)

Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration
Tmax will be calculated from plasma RCI001 concentration-time data after single administration.
Measured: Predose on Day -1 through Day 11
Maximum Observed Plasma Concentration (Cmax) of RCI001 After Single Administration
Cmax will be calculated from plasma RCI001 concentration-time data after single administration.
Measured: Predose on Day -1 through Day 25
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of RCI001 After Single Administration
AUClast will be calculated from plasma RCI001 concentration-time data after single administration.
Measured: Predose on Day -1 through Day 11.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of RCI001 After Single Administration
AUCinf will be calculated from plasma RCI001 concentration-time data after single administration.
Measured: Predose on Day -1 through Day 11.
Terminal Elimination Half-Life (t1/2) of RCI001 After Single Administration
Terminal elimination half-life will be calculated from plasma RCI001 concentration-time data after single administration.
Measured: Predose on Day -1 through Day 11.
Apparent Clearance (CL/F) of RCI001 After Single Administration
CL/F will be calculated from plasma RCI001 concentration-time data after single administration.
Measured: Predose on Day -1 through Day 11.
Apparent Volume of Distribution (Vz/F) of RCI001 After Single Administration
Vz/F will be calculated from plasma RCI001 concentration-time data after single administration.
Measured: Predose on Day -1 through Day 11.
Time to Maximum Plasma Concentration at Steady State (Tmax,ss) of RCI001 After Multiple Administration
Tmax,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.
Measured: Predose on Day -1 through Day 25.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of RCI001 After Multiple Administration
Cmax,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.
Measured: Predose on Day -1 through Day 25.
Minimum Observed Plasma Concentration at Steady State (Cmin,ss) of RCI001 After Multiple Administration
Cmin,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.
Measured: Predose on Day -1 through Day 25.
Average Plasma Concentration at Steady State (Cavg,ss) of RCI001 After Multiple Administration
Cavg,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.
Measured: Predose on Day -1 through Day 25.
Trough Plasma Concentration (Ctrough) of RCI001 After Multiple Administration
Ctrough will be calculated from plasma RCI001 concentration-time data after multiple administration.
Measured: Predose on Day -1 through Day 25.
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of RCI001 After Multiple Administration
AUCtau,ss will be calculated from plasma RCI001 concentration-time data after multiple administration.
Measured: Predose on Day -1 through Day 25.
Terminal Elimination Half-Life at Steady State (t1/2,ss) of RCI001 After Multiple Administration
Terminal elimination half-life at steady state will be calculated from plasma RCI001 concentration-time data after multiple administration.
Measured: Predose on Day -1 through Day 25.
Apparent Clearance at Steady State (CLss/F) of RCI001 After Multiple Administration
CLss/F will be calculated from plasma RCI001 concentration-time data after multiple administration.
Measured: Predose on Day -1 through Day 25.
Apparent Volume of Distribution at Steady State (Vz,ss/F) of RCI001 After Multiple Administration
Vz,ss/F will be calculated from plasma RCI001 concentration-time data after multiple administration.
Measured: Predose on Day -1 through Day 25.
Peak-to-Trough Fluctuation (PTF) of RCI001 After Multiple Administration
PTF will be calculated from plasma RCI001 concentration-time data after multiple administration.
Measured: Predose on Day -1 through Day 25.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202420 Sep 2025

First posted11 Jun 2026
Study start28 Oct 2024
Primary completion29 Aug 2025
Study completion20 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Dry EyeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07640867
Sponsor's protocol ID: RDC001_101
Status last verified: Jun 2026
First submitted: 12 May 2026
Last updated: 11 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be made available to other researchers. The study has been completed and the results are planned to be submitted for publication. De-identified individual participant-level data are not planned for external sharing due to participant confidentiality, informed consent, regulatory, legal, and proprietary considerations related to the investigational drug product. Aggregate results may be disclosed through ClinicalTrials.gov, scientific publication, and/or regulatory submissions, as applicable.

Publications

Im ST, Kim HY, Yoon JY, Oh JY, Kim MK, Chung MH, Paik HJ, Kim DH. Therapeutic Effects of Topical 8-Oxo-2'-deoxyguanosine on Ethanol-Induced Ocular Chemical Injury Models. Cornea. 2018 Oct;37(10):1311-1317. doi: 10.1097/ICO.0000000000001671.
PubMed 29923862
Kim DH, Im ST, Yoon JY, Kim S, Kim MK, Chung MH, Park CK. Comparison of therapeutic effects between topical 8-oxo-2'-deoxyguanosine and corticosteroid in ocular alkali burn model. Sci Rep. 2021 Mar 25;11(1):6909. doi: 10.1038/s41598-021-86440-7.
PubMed 33767351
Kim SH, Ku YA, Yoo C, Kim YH, Kim DH. Comparison of RCI001 and corticosteroid on the effects on intraocular pressure in mice. Front Med (Lausanne). 2023 Oct 9;10:1256569. doi: 10.3389/fmed.2023.1256569. eCollection 2023.
PubMed 37877019
Jung YH, Ku YA, Moon J, Kim S, Ryu JS, Yoon CH, Chung MH, Kim YH, Kim MK, Kim DH. Efficacy of RCI001 as a therapeutic candidate of dry eye disease in a modified mixed dry eye model. Eye Vis (Lond). 2024 Jun 1;11(1):19. doi: 10.1186/s40662-024-00388-z.
PubMed 38822444
Kim S, Jang YW, Ku YA, Shin Y, Rahman MM, Chung MH, Kim YH, Kim DH. Investigating the Anti-Inflammatory Effects of RCI001 for Treating Ocular Surface Diseases: Insight Into the Mechanism of Action. Front Immunol. 2022 Mar 24;13:850287. doi: 10.3389/fimmu.2022.850287. eCollection 2022.
PubMed 35401555
Chung H, Ha Y, Kim YH, Kim DH, Shin D. Ocular Distribution and Pharmacokinetics of 8-Oxo-2'-Deoxyguanosine: A Novel Therapeutic Candidate of Ocular Surface Diseases. J Ocul Pharmacol Ther. 2022 Oct;38(8):561-566. doi: 10.1089/jop.2022.0054.
PubMed 36288559

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Administration Phase 1 Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of RCI001 Eye Drops 0.25% in Healthy Male Subjects
ClinicalTrials.gov ID: NCT07640867
Acronym / sponsor ID: RDC001_101
Conditions: Dry Eye
Keywords: RCI001 Eye Drops, Dry Eye Diseases, Phase 1 Clinical Trial, Rudacure
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: RudacureIndustry (pharma, biotech, devices)
Study start: 28 Oct 2024 (actual)
Primary completion: 29 Aug 2025 (actual)
Study completion: 20 Sep 2025 (actual)
First posted: 11 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Approximately 40 healthy adult male participants are planned to take part in this study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
RCI001 Eye Drops 0.25%, Single-Day Administration, Once Daily	Experimental	Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Single-Day Administration, Once Daily	Placebo comparator	Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Daily	Experimental	Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Single-Day Administration, Twice Daily	Placebo comparator	Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Daily	Experimental	Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Single-Day Administration, Four Times Daily	Placebo comparator	Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Multiple-Day Administration, Twice Daily	Experimental	Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Multiple-Day Administration, Twice Daily	Placebo comparator	Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Multiple-Day Administration, Four Times Daily	Experimental	Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Multiple-Day Administration, Four Times Daily	Placebo comparator	Drug: Placebo Eye Drops

Who may qualify

Ages: 19 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy adult male volunteers aged 19 to 50 years at screening.
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.
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.
Participants who are considered eligible for this study by the investigator based on physical examination, clinical laboratory tests, medical interview, and other screening assessments.

Key exclusion criteria (5 listed)

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.
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.
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.
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.
Participants who are considered unsuitable for participation in the study by the investigator for any other reason.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RCI001 Eye Drops 0.25%Also: RCI001RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.	Drug	RCI001 Eye Drops 0.25%, Multiple-Day Administration, Four Times Daily, RCI001 Eye Drops 0.25%, Multiple-Day Administration, Twice Daily, RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Daily, RCI001 Eye Drops 0.25%, Single-Day Administration, Once Daily, RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Daily
Placebo Eye DropsAlso: Matching placeboMatching placebo eye drops administered to the left eye according to the assigned dosing schedule.	Drug	Placebo Eye Drops, Multiple-Day Administration, Four Times Daily, Placebo Eye Drops, Multiple-Day Administration, Twice Daily, Placebo Eye Drops, Single-Day Administration, Four Times Daily, Placebo Eye Drops, Single-Day Administration, Once Daily, Placebo Eye Drops, Single-Day Administration, Twice Daily

Primary outcome

Number of Participants With Adverse Events
Time frame: From informed consent through the post-study visit, up to Day 18 for single-administration cohorts and up to Day 32 for multiple-administration cohorts
The number and percentage of participants with adverse events will be summarized by treatment group. Adverse events will be assessed for seriousness, severity, relationship to the study drug, action taken, outcome, and whether they are treatment-emergent adverse events.
Number of Participants With Clinically Significant Abnormalities in Safety Assessments
Time frame: From baseline through the post-study visit, up to Day 18 for single-administration cohorts and up to Day 32 for multiple-administration cohorts
Safety assessments will include vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, ocular symptom assessments, and ophthalmic examinations. Clinically significant abnormalities will be summarized by treatment group.

17 secondary outcomes

Time to Maximum Plasma Concentration (Tmax) of RCI001 After Single Administration
Time frame: Predose on Day -1 through Day 11
Maximum Observed Plasma Concentration (Cmax) of RCI001 After Single Administration
Time frame: Predose on Day -1 through Day 25
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of RCI001 After Single Administration
Time frame: Predose on Day -1 through Day 11.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of RCI001 After Single Administration
Time frame: Predose on Day -1 through Day 11.
Terminal Elimination Half-Life (t1/2) of RCI001 After Single Administration
Time frame: Predose on Day -1 through Day 11.
Apparent Clearance (CL/F) of RCI001 After Single Administration
Time frame: Predose on Day -1 through Day 11.
Apparent Volume of Distribution (Vz/F) of RCI001 After Single Administration
Time frame: Predose on Day -1 through Day 11.
Time to Maximum Plasma Concentration at Steady State (Tmax,ss) of RCI001 After Multiple Administration
Time frame: Predose on Day -1 through Day 25.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of RCI001 After Multiple Administration
Time frame: Predose on Day -1 through Day 25.
Minimum Observed Plasma Concentration at Steady State (Cmin,ss) of RCI001 After Multiple Administration
Time frame: Predose on Day -1 through Day 25.
Average Plasma Concentration at Steady State (Cavg,ss) of RCI001 After Multiple Administration
Time frame: Predose on Day -1 through Day 25.
Trough Plasma Concentration (Ctrough) of RCI001 After Multiple Administration
Time frame: Predose on Day -1 through Day 25.
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of RCI001 After Multiple Administration
Time frame: Predose on Day -1 through Day 25.
Terminal Elimination Half-Life at Steady State (t1/2,ss) of RCI001 After Multiple Administration
Time frame: Predose on Day -1 through Day 25.
Apparent Clearance at Steady State (CLss/F) of RCI001 After Multiple Administration
Time frame: Predose on Day -1 through Day 25.
Apparent Volume of Distribution at Steady State (Vz,ss/F) of RCI001 After Multiple Administration
Time frame: Predose on Day -1 through Day 25.
Peak-to-Trough Fluctuation (PTF) of RCI001 After Multiple Administration
Time frame: Predose on Day -1 through Day 25.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
Background: PubMed 29923862Im ST, Kim HY, Yoon JY, Oh JY, Kim MK, Chung MH, Paik HJ, Kim DH. Therapeutic Effects of Topical 8-Oxo-2'-deoxyguanosine on Ethanol-Induced Ocular Chemical Injury Models. Cornea. 2018 Oct;37(10):1311-1317. doi: 10.1097/ICO.0000000000001671.
Background: PubMed 33767351Kim DH, Im ST, Yoon JY, Kim S, Kim MK, Chung MH, Park CK. Comparison of therapeutic effects between topical 8-oxo-2'-deoxyguanosine and corticosteroid in ocular alkali burn model. Sci Rep. 2021 Mar 25;11(1):6909. doi: 10.1038/s41598-021-86440-7.
Background: PubMed 37877019Kim SH, Ku YA, Yoo C, Kim YH, Kim DH. Comparison of RCI001 and corticosteroid on the effects on intraocular pressure in mice. Front Med (Lausanne). 2023 Oct 9;10:1256569. doi: 10.3389/fmed.2023.1256569. eCollection 2023.
Background: PubMed 38822444Jung YH, Ku YA, Moon J, Kim S, Ryu JS, Yoon CH, Chung MH, Kim YH, Kim MK, Kim DH. Efficacy of RCI001 as a therapeutic candidate of dry eye disease in a modified mixed dry eye model. Eye Vis (Lond). 2024 Jun 1;11(1):19. doi: 10.1186/s40662-024-00388-z.
Background: PubMed 35401555Kim S, Jang YW, Ku YA, Shin Y, Rahman MM, Chung MH, Kim YH, Kim DH. Investigating the Anti-Inflammatory Effects of RCI001 for Treating Ocular Surface Diseases: Insight Into the Mechanism of Action. Front Immunol. 2022 Mar 24;13:850287. doi: 10.3389/fimmu.2022.850287. eCollection 2022.
Background: PubMed 36288559Chung H, Ha Y, Kim YH, Kim DH, Shin D. Ocular Distribution and Pharmacokinetics of 8-Oxo-2'-Deoxyguanosine: A Novel Therapeutic Candidate of Ocular Surface Diseases. J Ocul Pharmacol Ther. 2022 Oct;38(8):561-566. doi: 10.1089/jop.2022.0054.
Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers. The study has been completed and the results are planned to be submitted for publication. De-identified individual participant-level data are not planned for external sharing due to participant confidentiality, informed consent, regulatory, legal, and proprietary considerations related to the investigational drug product. Aggregate results may be disclosed through ClinicalTrials.gov, scientific publication, and/or regulatory submissions, as applicable.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SeungHwan Lee, M.D., Ph.D. principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RCI001 Eye Drops 0.25% in people with Dry Eye, run by Rudacure at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: From informed consent through the post-study visit, up to Day 18 for single-administration cohorts and up to Day 32 for multiple-administration cohorts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07640867, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.