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

1. juni 2026 oppdatert av: Rudacure

A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a multi-center, randomized, double-masked, placebo-controlled Phase 2 study evaluating 0.25% RCI001 Ophthalmic Solution in participants with dry eye disease.

The study will include approximately 6 weeks of participation for each participant, consisting of a 2-week run-in period followed by a 4-week treatment period. Approximately 400 participants are expected to be screened, and approximately 200 eligible participants will be randomized, with approximately 50 participants assigned to each treatment group.

During the run-in period, participants who qualify at screening will receive placebo ophthalmic solution in both eyes according to either a twice-daily or four-times-daily dosing regimen. At the end of the run-in period, eligible participants will be randomized to continue the same dosing frequency and receive either 0.25% RCI001 Ophthalmic Solution or placebo ophthalmic solution bilaterally for 4 weeks.

The four treatment groups are:

0.25% RCI001 Ophthalmic Solution twice daily; placebo ophthalmic solution twice daily; 0.25% RCI001 Ophthalmic Solution four times daily; and placebo ophthalmic solution four times daily.

The study will include four scheduled visits: screening at Day -14, baseline/randomization at Day 1, follow-up at Day 14, and end-of-treatment/study exit at Day 28. Controlled Adverse Environment (CAE) assessments will be used as part of the study procedures.

The primary efficacy endpoints are total corneal fluorescein staining and ocular discomfort assessed before CAE exposure at Day 28. Secondary efficacy assessments include additional ocular staining measures, conjunctival redness, Schirmer's test, tear film break-up time, Ocular Surface Disease Index, ocular discomfort scores, visual analog scale symptoms, and daily symptom diary data.

Safety assessments include visual acuity, slit-lamp biomicroscopy, drop comfort, adverse event monitoring, intraocular pressure, and dilated fundoscopy. The study is designed to compare RCI001 with the corresponding placebo dosing regimen and to evaluate the optimal dosing frequency of RCI001 in the treatment of the signs and symptoms of dry eye disease.

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. At least 18 years of age at the Screening Visit (Visit 1), of either gender and any race.
  2. Able and willing to provide written informed consent.
  3. Willing and able to comply with all study procedures.
  4. Patient-reported history of dry eye for at least 6 months prior to Visit 1.
  5. History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.
  6. Best corrected visual acuity (BCVA) of 0.7 logMAR or better (Snellen equivalent of 20/100 or better) in each eye at Visit 1.
  7. 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.
  8. 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.

Exclusion Criteria:

  1. 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.
  2. Ongoing ocular infection, including bacterial, viral, or fungal infection, or active ocular inflammation at Visit 1.
  3. Contact lens wear within 7 days of Visit 1 or anticipated use of contact lenses during the study.
  4. LASIK surgery within the last 12 months.
  5. Female participant who is pregnant, nursing, or planning a pregnancy.
  6. 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.
  7. 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.
  8. Known allergy and/or sensitivity to the test article or its components.
  9. 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.
  10. Current enrollment in an investigational drug or device study or use of an investigational drug or device within 30 days of Visit 1.
  11. Unable or unwilling to follow instructions, including participation in all study assessments and visits.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: RCI001 Ophthalmic Solution BID
Participants will receive 0.25% RCI001 Ophthalmic Solution, one drop in each eye twice daily (BID), for 4 weeks.
Legemiddel: 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.
Andre navn:
  • 0.25% RCI001 Ophthalmic Solution
Placebo komparator: Placebo Ophthalmic Solution BID
Participants will receive placebo ophthalmic solution, one drop in each eye twice daily (BID), for 4 weeks.
Legemiddel: 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.
Andre navn:
  • Vehicle Ophthalmic Solution
Eksperimentell: RCI001 Ophthalmic Solution QID
Participants will receive 0.25% RCI001 Ophthalmic Solution, one drop in each eye four times daily (QID), for 4 weeks.
Legemiddel: 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.
Andre navn:
  • 0.25% RCI001 Ophthalmic Solution
Placebo komparator: Placebo Ophthalmic Solution QID
Participants will receive placebo ophthalmic solution, one drop in each eye four times daily (QID), for 4 weeks.
Legemiddel: 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.
Andre navn:
  • Vehicle Ophthalmic Solution

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Total Corneal Fluorescein Staining Score at Day 28
Tidsramme: Baseline to Day 28 (Week 4)
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
Tidsramme: Baseline to Day 28 (Week 4)
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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Fluorescein Staining Scores by Region
Tidsramme: Baseline to Day 14 and Day 28
Change from baseline in fluorescein staining scores by ocular region, including central, superior, inferior, temporal, and nasal regions, as well as summary staining scores, assessed using the Ora Calibra Corneal and Conjunctival Staining Scale. Each region is graded from 0 to 4, where 0 indicates no staining and 4 indicates confluent staining. Higher scores indicate more staining and worse ocular surface disease.
Baseline to Day 14 and Day 28
Change From Baseline in Conjunctival Lissamine Green Staining Scores by Region
Tidsramme: Baseline to Day 14 and Day 28
Change from baseline in conjunctival lissamine green staining scores by ocular region, including central, superior, inferior, temporal, and nasal regions, as well as summary staining scores, assessed using the Ora Calibra Corneal and Conjunctival Staining Scale. Each region is graded from 0 to 4, where 0 indicates no staining and 4 indicates confluent staining. Higher scores indicate more staining and worse ocular surface disease.
Baseline to Day 14 and Day 28
Change From Baseline in Conjunctival Redness Score
Tidsramme: Baseline to Day 14 and Day 28
Change from baseline in conjunctival redness score assessed using the Ora Calibra Conjunctival Redness Scale for Dry Eye. The scale ranges from 0 to 4, where 0 indicates normal without vasodilation and 4 indicates severe redness. Higher scores indicate worse conjunctival redness.
Baseline to Day 14 and Day 28
Change From Baseline in Schirmer's Test Score
Tidsramme: Baseline to Day 14 and Day 28
Change from baseline in Schirmer's test value. Schirmer's test measures tear production using the length of wetting on a Schirmer test strip after 5 minutes. The unit of measure is millimeters (mm), and higher values indicate greater tear production.
Baseline to Day 14 and Day 28
Change From Baseline in Tear Film Break-Up Time
Tidsramme: Baseline to Day 14 and Day 28
Change from baseline in tear film break-up time (TFBUT). TFBUT measures the time from eye opening to the first appearance of tear film break-up after fluorescein instillation. The unit of measure is seconds, and higher values indicate greater tear film stability.
Baseline to Day 14 and Day 28
Change From Baseline in Ocular Surface Disease Index Score
Tidsramme: Baseline to Day 14 and Day 28
Change from baseline in Ocular Surface Disease Index (OSDI) score assessed before Controlled Adverse Environment (CAE) exposure. The OSDI is a participant-reported questionnaire scored from 0 to 100, where higher scores indicate greater dry eye symptom severity and vision-related functional impairment.
Baseline to Day 14 and Day 28
Change From Baseline in Ocular Discomfort Scale Score
Tidsramme: Baseline to Day 14 and Day 28
Change from baseline in ocular discomfort score assessed 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 14 and Day 28
Change From Baseline in Visual Analog Scale Symptom Scores
Tidsramme: Baseline to Day 14 and Day 28
Change from baseline in participant-reported dry eye symptom scores assessed using a visual analog scale (VAS). The VAS is scored from 0 to 100, where higher scores indicate greater symptom severity.
Baseline to Day 14 and Day 28
Change From Baseline in Ocular Discomfort and 4-Symptom Questionnaire Score
Tidsramme: Baseline to Day 14 and Day 28
Change from baseline in participant-reported ocular discomfort and dry eye symptom scores assessed using the Ora Calibra Ocular Discomfort and 4-Symptom Questionnaire for Dry Eye. Participants rate overall ocular discomfort, burning, dryness, grittiness, and stinging on a 0 to 5 scale, where 0 indicates none and 5 indicates worst. Higher scores indicate worse symptoms.
Baseline to Day 14 and Day 28
Change From Baseline in Daily Symptom Diary Scores
Tidsramme: Baseline to Day 28
Change from baseline in participant-reported daily dry eye symptom diary scores collected during the treatment period using the Ora Calibra Ocular Discomfort and 4-Symptom Questionnaire for Dry Eye. Symptoms are rated on a 0 to 5 scale, where 0 indicates none and 5 indicates worst. Higher scores indicate worse symptoms.
Baseline to Day 28

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Treatment-Emergent Adverse Events
Tidsramme: From first dose through Day 28
Number and percentage of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to premature discontinuation. Adverse events will be coded using MedDRA and summarized by treatment group.
From first dose through Day 28
Change From Baseline in Visual Acuity
Tidsramme: Baseline to Day 28
Change from baseline in best-corrected visual acuity (BCVA). The unit of measure is change in visual acuity value, such as logMAR or ETDRS-based score, as collected in the study.
Baseline to Day 28
Change From Baseline in Intraocular Pressure
Tidsramme: Baseline to Day 28
Change from baseline in intraocular pressure (IOP) measured in each eye by contact tonometry. The unit of measure is mmHg.
Baseline to Day 28
Slit-Lamp Biomicroscopy Findings
Tidsramme: Baseline to Day 28
Number and percentage of participants with slit-lamp biomicroscopy findings, including clinically significant and non-clinically significant ocular findings, as determined by the investigator.
Baseline to Day 28
Dilated Fundoscopy Findings
Tidsramme: Baseline to Day 28
Number and percentage of participants with dilated fundoscopy findings, including clinically significant and non-clinically significant posterior segment findings, as determined by the investigator.
Baseline to Day 28
Mean Ora Calibra Drop Comfort Scale Score After Initial Dosing
Tidsramme: Immediately after initial dosing and at 1 and 2 minutes after initial dosing
Mean subject-reported drop comfort score assessed for each eye using the Ora Calibra Drop Comfort Scale after initial dosing at Visit 2. The Ora Calibra Drop Comfort Scale is an 11-point scale ranging from 0 to 10, where 0 indicates very comfortable and 10 indicates very uncomfortable.
Immediately after initial dosing and at 1 and 2 minutes after initial dosing
Subject-Reported Drop Comfort Descriptors After Initial Dosing
Tidsramme: 3 minutes after initial dosing
Subject-reported drop comfort descriptors assessed using the Ora Calibra Drop Comfort Questionnaire at 3 minutes after initial dosing at Visit 2. Participants will select words that best describe how the eye drops feel in both eyes. The unit of measure will be the number and percentage of participants selecting each descriptor.
3 minutes after initial dosing

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Rudacure

Etterforskere

  • Studieleder: Yuseung Ha, Rudacure

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2027

Primær fullføring (Antatt)

30. juni 2028

Studiet fullført (Antatt)

30. august 2028

Datoer for studieregistrering

Først innsendt

12. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RDC001_201

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be made available to other researchers. The study is sponsored by RudaCure Corporation and involves an investigational drug product. De-identified individual participant-level data are not planned for external sharing due to participant confidentiality, informed consent, regulatory, legal, and proprietary considerations. Aggregate study results may be disclosed through ClinicalTrials.gov, publications, and/or regulatory submissions, as applicable.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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