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
Qualifiers
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
Treatments tested in this trial
- RCI001 Ophthalmic Solution
- Placebo Ophthalmic Solution
Treatment groups
200 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov