Dry Eye DiseasePhase 1/2NCT06400459
IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease
A Phase 1/2 study testing IVW-1001 Ophthalmic Eyelid Wipe 0.1% and IVW-1001 Ophthalmic Eyelid Wipe 0.2% in people with Dry Eye Disease, run by IVIEW Therapeutics Inc. at 1 site in United States.
Trial summary
Double-masked, dose-response, trial of IVW-1001 in subjects 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 Disease
- What is being tested?
- IVW-1001 Ophthalmic Eyelid Wipe 0.1% and IVW-1001 Ophthalmic Eyelid Wipe 0.2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to 15 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects of any gender at least 18 years of age at the Screening Visit
- Able to voluntarily provide written informed consent to participate in the study
- Able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits
- Diagnosis of Dry Eye Disease (DED)
Who cannot join
- Corneal fluorescein staining score of 4 using the NEI grading system
- Intraocular pressure ≥23 mmHg
- History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
- Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1/2a, Proof-of-Concept, Multicenter, Parallel, Vehicle-Controlled, Double-Masked, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of IVW-1001 Ophthalmic Eyelid Wipe in Subjects With Dry Eye Disease
Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.
Read the detailed description
This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle). Subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.
- Conditions
- Dry Eye Disease
- Being tested
- IVW-1001 Ophthalmic Eyelid Wipe 0.1%, IVW-1001 Ophthalmic Eyelid Wipe 0.2%, IVW-1001 Placebo
- 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.
IVW-1001 Ophthalmic Eyelid Wipe 0.1%Drug
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
IVW-1001 Ophthalmic Eyelid Wipe 0.2%Drug
IVW-1001 Ophthalmic Eyelid Wipe 0.2%
IVW-1001 PlaceboDrug
IVW-1001 Placebo
| Study group | Role | What they receive |
|---|---|---|
| IVW-1001 0.1% | Experimental | IVW-1001 Ophthalmic Eyelid Wipe 0.1% Receives: Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.1% |
| IVW-1001 0.2% | Experimental | IVW-1001 Ophthalmic Eyelid Wipe 0.1% Receives: Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2% |
| IVW-1001 Placebo | Placebo comparator | Vehicle Receives: Drug: IVW-1001 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's
Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness)
Measured: 29 Days
Secondary outcomes (5)
Visual Acuity
Mean change from baseline in best corrected visual acuity
Measured: 29 Days
Total Corneal Fluorescein Staining Score in the Study Eye
Change from baseline in score on a scale (0 - none - to 20 - severe)
Measured: Week 4
Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score
Change from Baseline in the SANDE visual analog scale (0 - none to 100 - severe)
Measured: Week 4
Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score
Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)
Measured: 4 weeks
Symptom Assessment in Dry Eye (SANDE): Global Score
Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start25 Jun 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-masked
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVIEW Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bo Liang, PhD, Study director, IVIEW Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400459
- Sponsor's protocol ID
- IVW-1001-CS-101
- Status last verified
- Jan 2026
- First submitted
- 1 May 2024
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a, Proof-of-Concept, Multicenter, Parallel, Vehicle-Controlled, Double-Masked, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of IVW-1001 Ophthalmic Eyelid Wipe in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06400459
- Acronym / sponsor ID
- IVW-1001-CS-101
- Conditions
- Dry Eye Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- IVIEW Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Posted 12 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.
Detailed description
This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle). Subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-masked
| Arm | Type | Receives |
|---|---|---|
| IVW-1001 0.1% | Experimental | Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.1%IVW-1001 Ophthalmic Eyelid Wipe 0.1% |
| IVW-1001 0.2% | Experimental | Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%IVW-1001 Ophthalmic Eyelid Wipe 0.1% |
| IVW-1001 Placebo | Placebo comparator | Drug: IVW-1001 PlaceboVehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects of any gender at least 18 years of age at the Screening Visit
- Able to voluntarily provide written informed consent to participate in the study
- Able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits
- Diagnosis of Dry Eye Disease (DED)
Key exclusion criteria (4 listed)
- Corneal fluorescein staining score of 4 using the NEI grading system
- Intraocular pressure ≥23 mmHg
- History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
- Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED
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 |
|---|---|---|
| IVW-1001 Ophthalmic Eyelid Wipe 0.1%IVW-1001 Ophthalmic Eyelid Wipe 0.1% | Drug | IVW-1001 0.1% |
| IVW-1001 Ophthalmic Eyelid Wipe 0.2%IVW-1001 Ophthalmic Eyelid Wipe 0.2% | Drug | IVW-1001 0.2% |
| IVW-1001 PlaceboIVW-1001 Placebo | Drug | IVW-1001 Placebo |
Primary outcome
Schirmer's
Time frame: 29 Days
Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness)
5 secondary outcomes
Visual Acuity
Time frame: 29 Days
Total Corneal Fluorescein Staining Score in the Study Eye
Time frame: Week 4
Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score
Time frame: Week 4
Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score
Time frame: 4 weeks
Symptom Assessment in Dry Eye (SANDE): Global Score
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Bo Liang, PhD study director
IVIEW Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IVW-1001 Ophthalmic Eyelid Wipe 0.1% and IVW-1001 Ophthalmic Eyelid Wipe 0.2% in people with Dry Eye Disease, run by IVIEW Therapeutics Inc. at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 12 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer's (time frame: 29 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.