A Phase 2 Study of RCI001 Ophthalmic Solution in Participants With Dry Eye Disease
ConditionDry Eye
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRudacure
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
RCI001 Ophthalmic Solution
DrugRCI001 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.
Placebo Ophthalmic Solution
DrugPlacebo 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.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: RCI001 Ophthalmic Solution BIDExperimental treatment 1 intervention
Group B: Placebo Ophthalmic Solution BIDPlacebo comparator 1 intervention
Group C: RCI001 Ophthalmic Solution QIDExperimental treatment 1 intervention
Group D: Placebo Ophthalmic Solution QIDPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Day 28 (Week 4)2
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.
Time frame
Baseline to Day 28 (Week 4)Secondary outcomes
1
Change From Baseline in Fluorescein Staining Scores by Region
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.
Time frame
Baseline to Day 14 and Day 282
Change From Baseline in Conjunctival Lissamine Green Staining Scores by Region
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.
Time frame
Baseline to Day 14 and Day 283
Change From Baseline in Conjunctival Redness Score
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.
Time frame
Baseline to Day 14 and Day 284
Change From Baseline in Schirmer's Test Score
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.
Time frame
Baseline to Day 14 and Day 28Other outcomes
1
Incidence of Treatment-Emergent Adverse Events
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.
Time frame
From first dose through Day 282
Change From Baseline in Visual Acuity
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.
Time frame
Baseline to Day 283
Change From Baseline in Intraocular Pressure
Change from baseline in intraocular pressure (IOP) measured in each eye by contact tonometry. The unit of measure is mmHg.
Time frame
Baseline to Day 284
Slit-Lamp Biomicroscopy Findings
Number and percentage of participants with slit-lamp biomicroscopy findings, including clinically significant and non-clinically significant ocular findings, as determined by the investigator.
Time frame
Baseline to Day 28Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: