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

1 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: RCI001 Ophthalmic Solution BID
Participants will receive 0.25% RCI001 Ophthalmic Solution, one drop in each eye twice daily (BID), for 4 weeks.
Droga: 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.
Altri nomi:
  • 0.25% RCI001 Ophthalmic Solution
Comparatore placebo: Placebo Ophthalmic Solution BID
Participants will receive placebo ophthalmic solution, one drop in each eye twice daily (BID), for 4 weeks.
Droga: 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.
Altri nomi:
  • Vehicle Ophthalmic Solution
Sperimentale: RCI001 Ophthalmic Solution QID
Participants will receive 0.25% RCI001 Ophthalmic Solution, one drop in each eye four times daily (QID), for 4 weeks.
Droga: 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.
Altri nomi:
  • 0.25% RCI001 Ophthalmic Solution
Comparatore placebo: Placebo Ophthalmic Solution QID
Participants will receive placebo ophthalmic solution, one drop in each eye four times daily (QID), for 4 weeks.
Droga: 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.
Altri nomi:
  • Vehicle Ophthalmic Solution

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Total Corneal Fluorescein Staining Score at Day 28
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Fluorescein Staining Scores by Region
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Treatment-Emergent Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Rudacure

Investigatori

  • Direttore dello studio: Yuseung Ha, Rudacure

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2027

Completamento primario (Stimato)

30 giugno 2028

Completamento dello studio (Stimato)

30 agosto 2028

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RDC001_201

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Occhio secco

Prove cliniche su RCI001 Ophthalmic Solution

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Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Pakistan

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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