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A Phase 2 Study of RCI001 Ophthalmic Solution in Participants With Dry Eye Disease

NCT07625124 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-04

No results posted yet for this study

Summary

This is a Phase 2 clinical study designed to evaluate the safety and efficacy of 0.25% RCI001 Ophthalmic Solution compared with placebo in participants with dry eye disease.

The study will enroll adults with dry eye disease. After a 2-week run-in period with placebo ophthalmic solution, eligible participants will be randomly assigned to receive either 0.25% RCI001 Ophthalmic Solution or placebo ophthalmic solution in both eyes for 4 weeks. Study treatment will be administered either twice daily or four times daily, depending on the assigned dosing regimen.

The main purpose of the study is to determine whether RCI001 improves the signs and symptoms of dry eye disease compared with placebo. The primary assessments include total corneal fluorescein staining and ocular discomfort at Day 28. Safety will be assessed through eye examinations, visual acuity, intraocular pressure, drop comfort, and adverse event monitoring.

Conditions

  • Dry Eye

Interventions

DRUG

RCI001 Ophthalmic Solution

RCI001 Ophthalmic Solution is a topical ophthalmic investigational drug containing 0.25% RCI001. Participants assigned to RCI001 treatment will receive one drop in each eye either twice daily (BID) or four times daily (QID), depending on the assigned treatment arm, for 4 weeks.

DRUG

Placebo Ophthalmic Solution

Placebo Ophthalmic Solution is a topical ophthalmic vehicle solution that has the same formulation as RCI001 Ophthalmic Solution but does not contain the active ingredient, RCI001. Participants assigned to placebo treatment will receive one drop in each eye either twice daily (BID) or four times daily (QID), depending on the assigned treatment arm, for 4 weeks.

Sponsors & Collaborators

  • Rudacure

    lead INDUSTRY

Principal Investigators

  • Yuseung Ha · Rudacure

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-09-01
Primary Completion
2028-06-30
Completion
2028-08-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07625124 on ClinicalTrials.gov