CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled / 40 target
Drug / intervention
RCI001 Eye Drops 0.25% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07640867
NCT07640867Phase 1CompletedHigh Momentum (2.0/mo)Completion was 10mo ago
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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

Rudacure·interventional·Posted Jun 11, 2026·Updated Jun 11, 2026

In Brief

A Phase 1 clinical trial evaluating RCI001 Eye Drops 0.25% and Placebo Eye Drops for Dry Eye. Completed, enrolled 40 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesSouth Korea
Collaborators--

Timeline

Phase 1CompletedFinished
20252026
First PostedJun 11, 2026
Enrollment StartOct 28, 2024
Primary CompletionAug 29, 2025
Study CompletionSep 20, 2025
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 21 days ago

Arms & Interventions

RCI001 Eye Drops 0.25%, Single-Day Administration, Once Dailyexperimental

Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Single-Day Administration, Once Dailyplacebo_comparator

Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Single-Day Administration, Twice Dailyexperimental

Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Single-Day Administration, Twice Dailyplacebo_comparator

Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Single-Day Administration, Four Times Dailyexperimental

Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Single-Day Administration, Four Times Dailyplacebo_comparator

Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Multiple-Day Administration, Twice Dailyexperimental

Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Multiple-Day Administration, Twice Dailyplacebo_comparator

Drug: Placebo Eye Drops
RCI001 Eye Drops 0.25%, Multiple-Day Administration, Four Times Dailyexperimental

Drug: RCI001 Eye Drops 0.25%
Placebo Eye Drops, Multiple-Day Administration, Four Times Dailyplacebo_comparator

Drug: Placebo Eye Drops

Interventions

RCI001 Eye Drops 0.25%drug

RCI001 eye drops 0.25% administered to the left eye according to the assigned dosing schedule.

Placebo Eye Dropsdrug

Matching placebo eye drops administered to the left eye according to the assigned dosing schedule.