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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Dry Eye

In brief

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.

Key facts

Study ID

NCT07625124

Run by

Rudacure

People needed

200

Starts

2027-09-01

Expected to finish

2028-08-30

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age at the Screening Visit (Visit 1), of either gender and any race.
• Able and willing to provide written informed consent.
• Willing and able to comply with all study procedures.
• Patient-reported history of dry eye for at least 6 months prior to Visit 1.
• History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.
• Best corrected visual acuity (BCVA) of 0.7 logMAR or better (Snellen equivalent of 20/100 or better) in each eye at Visit 1.
• At least one eye, the same eye, must satisfy all criteria for Schirmer's Test, corneal fluorescein staining, conjunctival lissamine green staining, conjunctival redness, and CAE response.
• Female participants of childbearing potential must have a negative urine pregnancy test and must use adequate birth control throughout the study period. For non-sexually active females, abstinence may be regarded as an adequate method of birth control.

You may not qualify if…

• Clinically significant slit-lamp findings at Visit 1, including active blepharitis, meibomian gland dysfunction, severe lid margin inflammation, or active ocular allergies requiring therapeutic treatment, and/or findings that in the opinion of the investigator may interfere with study parameters. Participants with moderate to severe meibomian gland dysfunction, in the opinion of the investigator, are not eligible.
• Ongoing ocular infection, including bacterial, viral, or fungal infection, or active ocular inflammation at Visit 1.
• Contact lens wear within 7 days of Visit 1 or anticipated use of contact lenses during the study.
• LASIK surgery within the last 12 months.
• Female participant who is pregnant, nursing, or planning a pregnancy.
• Female participant of childbearing potential who is unwilling to submit a urine pregnancy test at Visit 1 and Visit 4, or at an early termination visit.
• Female participant of childbearing potential who is not using an acceptable method of birth control. Acceptable methods include hormonal contraceptives, mechanical contraception with spermicide and a barrier method, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as adequate; however, if the participant becomes sexually active during the study, she must agree to use adequate birth control for the remainder of the study.
• Known allergy and/or sensitivity to the test article or its components.
• Any condition or situation that, in the investigator's opinion, may put the participant at significant risk, may confound study results, or may interfere significantly with participation in the study.
• Current enrollment in an investigational drug or device study or use of an investigational drug or device within 30 days of Visit 1.
• Unable or unwilling to follow instructions, including participation in all study assessments and visits.

Full record on ClinicalTrials.gov

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