Dry EyePhase 2NCT07625124
A Phase 2 Study of RCI001 Ophthalmic Solution in Participants With Dry Eye Disease
A Phase 2 study testing RCI001 Ophthalmic Solution in people with Dry Eye, run by Rudacure.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- RCI001 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2027to 30 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Seunghoon Kim contact
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Dry Eye
- Being tested
- RCI001 Ophthalmic Solution, Placebo Ophthalmic Solution
- Keywords
- RCI001, Phase 2, Rudacure
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RCI001 Ophthalmic SolutionDrug
Also called 0.25% 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.
Placebo Ophthalmic SolutionDrug
Also called Vehicle 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.
| Study group | Role | What they receive |
|---|---|---|
| RCI001 Ophthalmic Solution BID | Experimental | Participants will receive 0.25% RCI001 Ophthalmic Solution, one drop in each eye twice daily (BID), for 4 weeks. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Day 28 (Week 4)
Secondary outcomes (10)
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.
Measured: Baseline to Day 14 and Day 28
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.
Measured: Baseline to Day 14 and Day 28
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.
Measured: Baseline to Day 14 and Day 28
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.
Measured: Baseline to Day 14 and Day 28
Change From Baseline in Tear Film Break-Up Time
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.
Measured: Baseline to Day 14 and Day 28
Change From Baseline in Ocular Surface Disease Index Score
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.
Measured: Baseline to Day 14 and Day 28
Change From Baseline in Ocular Discomfort Scale Score
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.
Measured: Baseline to Day 14 and Day 28
Change From Baseline in Visual Analog Scale Symptom Scores
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.
Measured: Baseline to Day 14 and Day 28
Change From Baseline in Ocular Discomfort and 4-Symptom Questionnaire Score
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.
Measured: Baseline to Day 14 and Day 28
Change From Baseline in Daily Symptom Diary Scores
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.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Sep 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rudacure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuseung Ha, Study director, Rudacure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625124
- Sponsor's protocol ID
- RDC001_201
- Status last verified
- Jun 2026
- First submitted
- 12 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26365210Mah 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.
PubMed 23226002Schaumberg 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.
PubMed 19506195Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clin Ophthalmol. 2009;3:405-12. doi: 10.2147/opth.s5555. Epub 2009 Jul 14.
PubMed 19688028Bron 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.
PubMed 28736340
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07625124
- Acronym / sponsor ID
- RDC001_201
- Conditions
- Dry Eye
- Keywords
- RCI001, Phase 2, Rudacure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RudacureIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| RCI001 Ophthalmic Solution BID | Experimental | Drug: RCI001 Ophthalmic SolutionParticipants will receive 0.25% RCI001 Ophthalmic Solution, one drop in each eye twice daily (BID), for 4 weeks. |
| Placebo Ophthalmic Solution BID | Placebo comparator | Drug: Placebo Ophthalmic SolutionParticipants will receive placebo ophthalmic solution, one drop in each eye twice daily (BID), for 4 weeks. |
| RCI001 Ophthalmic Solution QID | Experimental | Drug: RCI001 Ophthalmic SolutionParticipants will receive 0.25% RCI001 Ophthalmic Solution, one drop in each eye four times daily (QID), for 4 weeks. |
| Placebo Ophthalmic Solution QID | Placebo comparator | Drug: Placebo Ophthalmic SolutionParticipants will receive placebo ophthalmic solution, one drop in each eye four times daily (QID), for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RCI001 Ophthalmic SolutionAlso: 0.25% RCI001 Ophthalmic SolutionRCI001 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. | Drug | RCI001 Ophthalmic Solution BID, RCI001 Ophthalmic Solution QID |
| Placebo Ophthalmic SolutionAlso: Vehicle Ophthalmic SolutionPlacebo 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. | Drug | Placebo Ophthalmic Solution BID, Placebo Ophthalmic Solution QID |
Primary outcome
Change From Baseline in Total Corneal Fluorescein Staining Score at Day 28
Time frame: 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.
Change From Baseline in Ocular Discomfort Score at Day 28
Time frame: 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.
10 secondary outcomes
Change From Baseline in Fluorescein Staining Scores by Region
Time frame: Baseline to Day 14 and Day 28
Change From Baseline in Conjunctival Lissamine Green Staining Scores by Region
Time frame: Baseline to Day 14 and Day 28
Change From Baseline in Conjunctival Redness Score
Time frame: Baseline to Day 14 and Day 28
Change From Baseline in Schirmer's Test Score
Time frame: Baseline to Day 14 and Day 28
Change From Baseline in Tear Film Break-Up Time
Time frame: Baseline to Day 14 and Day 28
Change From Baseline in Ocular Surface Disease Index Score
Time frame: Baseline to Day 14 and Day 28
Change From Baseline in Ocular Discomfort Scale Score
Time frame: Baseline to Day 14 and Day 28
Change From Baseline in Visual Analog Scale Symptom Scores
Time frame: Baseline to Day 14 and Day 28
Change From Baseline in Ocular Discomfort and 4-Symptom Questionnaire Score
Time frame: Baseline to Day 14 and Day 28
Change From Baseline in Daily Symptom Diary Scores
Time frame: Baseline to Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 26365210Tauber 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.
- Background: PubMed 23226002Mah 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.
- Background: PubMed 19506195Schaumberg 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.
- Background: PubMed 19688028Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clin Ophthalmol. 2009;3:405-12. doi: 10.2147/opth.s5555. Epub 2009 Jul 14.
- Results publication: PubMed 28736340Bron 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seunghoon Kim contact
Yuseung Ha study director
Rudacure
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RCI001 Ophthalmic Solution in people with Dry Eye, run by Rudacure.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuseung Ha (+8207075991644, yuseung.ha@rudacure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total Corneal Fluorescein Staining Score at Day 28 (time frame: Baseline to Day 28 (Week 4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07625124, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.