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

NCT07625124 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RDC001_201
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

RCI001; Phase 2; Rudacure

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Total Corneal Fluorescein Staining Score at Day 28

  Change from baseline in total corneal fluorescein staining score in the study eye, assessed before Controlled Adverse Environment (CAE) exposure at Day 28 using the Ora Calibra Corneal and Conjunctival Staining Scale. Each ocular surface region is graded from 0 to 4, where 0 indicates no staining and 4 indicates confluent staining. The total score is the sum of the assessed regions, and higher scores indicate more staining and worse ocular surface disease.

  Baseline to Day 28 (Week 4)

• Change From Baseline in Ocular Discomfort Score at Day 28

  Change from baseline in ocular discomfort score in the study eye, assessed before Controlled Adverse Environment (CAE) exposure at Day 28 using the Ora Calibra Ocular Discomfort Scale for Dry Eye. The scale ranges from 0 to 4, where 0 indicates no discomfort and 4 indicates constant discomfort. Higher scores indicate worse ocular discomfort.

  Baseline to Day 28 (Week 4)

Secondary Outcomes (10)

• Change From Baseline in Fluorescein Staining Scores by Region

  Baseline to Day 14 and Day 28

• Change From Baseline in Conjunctival Lissamine Green Staining Scores by Region

  Baseline to Day 14 and Day 28

• Change From Baseline in Conjunctival Redness Score

  Baseline to Day 14 and Day 28

• Change From Baseline in Schirmer's Test Score

  Baseline to Day 14 and Day 28

• Change From Baseline in Tear Film Break-Up Time

  Baseline to Day 14 and Day 28

Other Outcomes (7)

• Incidence of Treatment-Emergent Adverse Events

  From first dose through Day 28

• Change From Baseline in Visual Acuity

  Baseline to Day 28

• Change From Baseline in Intraocular Pressure

  Baseline to Day 28

Study Arms (4)

RCI001 Ophthalmic Solution BID

EXPERIMENTAL

Participants will receive 0.25% RCI001 Ophthalmic Solution, one drop in each eye twice daily (BID), for 4 weeks.

Drug: RCI001 Ophthalmic Solution

Placebo Ophthalmic Solution BID

PLACEBO COMPARATOR

Participants will receive placebo ophthalmic solution, one drop in each eye twice daily (BID), for 4 weeks.

Drug: Placebo Ophthalmic Solution

RCI001 Ophthalmic Solution QID

EXPERIMENTAL

Participants will receive 0.25% RCI001 Ophthalmic Solution, one drop in each eye four times daily (QID), for 4 weeks.

Drug: RCI001 Ophthalmic Solution

Placebo Ophthalmic Solution QID

PLACEBO COMPARATOR

Participants will receive placebo ophthalmic solution, one drop in each eye four times daily (QID), for 4 weeks.

Drug: Placebo Ophthalmic Solution

Interventions

RCI001 Ophthalmic Solution DRUG

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.

Also known as: 0.25% RCI001 Ophthalmic Solution

RCI001 Ophthalmic Solution BID; RCI001 Ophthalmic Solution QID

Placebo Ophthalmic Solution DRUG

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.

Also known as: Vehicle Ophthalmic Solution

Placebo Ophthalmic Solution BID; Placebo Ophthalmic Solution QID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Rudacure: lead

Related Publications (5)

• Tauber J, Karpecki P, Latkany R, Luchs J, Martel J, Sall K, Raychaudhuri A, Smith V, Semba CP; OPUS-2 Investigators. Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study. Ophthalmology. 2015 Dec;122(12):2423-31. doi: 10.1016/j.ophtha.2015.08.001. Epub 2015 Sep 11.

  PMID: 26365210 BACKGROUND

• Mah F, Milner M, Yiu S, Donnenfeld E, Conway TM, Hollander DA. PERSIST: Physician's Evaluation of Restasis((R)) Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clin Ophthalmol. 2012;6:1971-6. doi: 10.2147/OPTH.S30261. Epub 2012 Nov 28.

  PMID: 23226002 BACKGROUND

• Schaumberg DA, Dana R, Buring JE, Sullivan DA. Prevalence of dry eye disease among US men: estimates from the Physicians' Health Studies. Arch Ophthalmol. 2009 Jun;127(6):763-8. doi: 10.1001/archophthalmol.2009.103.

  PMID: 19506195 BACKGROUND

• Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clin Ophthalmol. 2009;3:405-12. doi: 10.2147/opth.s5555. Epub 2009 Jul 14.

  PMID: 19688028 BACKGROUND

• Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.

  PMID: 28736340 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Yuseung Ha

  Rudacure

  STUDY DIRECTOR

Central Study Contacts

Yuseung Ha

CONTACT

+8207075991644; yuseung.ha@rudacure.com

Seunghoon Kim

CONTACT

sh.kim@rudacure.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-masked study. Participants and investigators will be masked to treatment assignment. The sponsor, CRO, and site personnel will also be masked to treatment assignment. The placebo ophthalmic solution has the same formulation as RCI001 Ophthalmic Solution except that it does not contain the active ingredient, and the placebo container is identical to the RCI001 Ophthalmic Solution container.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants who meet eligibility criteria after the run-in period will be randomized to one of four parallel treatment groups: 0.25% RCI001 Ophthalmic Solution twice daily, placebo ophthalmic solution twice daily, 0.25% RCI001 Ophthalmic Solution four times daily, or placebo ophthalmic solution four times daily. Treatment will be administered bilaterally for 4 weeks.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share