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Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 200
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: RudacureUpdated: Jun 4, 2026
Eligibility criteria

At least 18 years of age at the Screening Visit (Visit 1), of either gender and... [+7]

Clinically significant slit-lamp findings at Visit 1, including active blepharit... [+10]