Dry EyePhase 2NCT07161011
Phase 2b Controlled Study of Dosing Techniques - Part B
A Phase 2 study testing IVW-1001 Ophthalmic Eyelid Wipe 0.2% and IVW-1001 Ophthalmic Eyelid Wipe 0.4% in people with Dry Eye, run by IVIEW Therapeutics Inc. at 1 site in United States.
Trial summary
Double-masked, dose-response of two concentrations of IVW-1001 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?
- IVW-1001 Ophthalmic Eyelid Wipe 0.2% and IVW-1001 Ophthalmic Eyelid Wipe 0.4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 3 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Self-reported diagnosis of DED in one or both eyes
- BCVA +0.70 logarithm of minimum angle of refraction (Snellen equivalent 20/100) or better in each eye at the Screening Visit
- For women of childbearing potential, confirmed negative pregnancy test at the Screening Visit, not nursing a child, and willing to comply with one of the acceptable methods of birth control described in the protocol
- History (by subject recollection) of artificial tear use within 30 days prior to the Screening Visit
- Unanesthetized Schirmer's test score 5-19 mm inclusive in at least 1 eye (same eye) at the Screening Visit and the Baseline Visit
Who cannot join
- Corneal fluorescein staining score of 4 in either eye in any zone using the National Eye Institute grading system at either the Screening Visit or the Baseline Visit
- IOP ≥23 mmHg in either eye at either the Screening Visit or the Baseline Visit
- History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Research Foundation
Newport Beach, California, 92663
About this study
Official title: Phase 2b, Proof-of-Concept, Single-center, Double-Masked, Randomized Study Comparing the Safety, Tolerability, and Efficacy of Three Different Ophthalmic Eyelid Wipe Dosing Techniques Using IVW-1001 in Subjects With Dry Eye Disease
Double-masked, dose-response of two concentrations of IVW-1001
Read the detailed description
Using the best dosing technique from Study NCT07140380, subjects will be randomized to one of two concentrations.
- Conditions
- Dry Eye
- Being tested
- IVW-1001 Ophthalmic Eyelid Wipe 0.2%, IVW-1001 Ophthalmic Eyelid Wipe 0.4%
- Keywords
- Dry Eye
- 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 0.2%Drug
Low dose
IVW-1001 Ophthalmic Eyelid Wipe 0.4%Drug
High dose
| Study group | Role | What they receive |
|---|---|---|
| IVW-1001 0.2% | Experimental | Ophthalmic Eyelid wipe Receives: Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2% |
| IVW-1001 0.4% | Experimental | Ophthalmic Eyelid Wipe Receives: Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unanesthetized Schirmer test
Tear production
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start8 Sep 2025
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double-masked, randomized, parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVIEW Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161011
- Sponsor's protocol ID
- IVW-1001-CS-202B
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b, Proof-of-Concept, Single-center, Double-Masked, Randomized Study Comparing the Safety, Tolerability, and Efficacy of Three Different Ophthalmic Eyelid Wipe Dosing Techniques Using IVW-1001 in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07161011
- Acronym / sponsor ID
- IVW-1001-CS-202B
- Conditions
- Dry Eye
- Keywords
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- IVIEW Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 8 Sep 2025 (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.
Double-masked, dose-response of two concentrations of IVW-1001
Detailed description
Using the best dosing technique from Study NCT07140380, subjects will be randomized to one of two concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-masked, randomized, parallel
| Arm | Type | Receives |
|---|---|---|
| IVW-1001 0.2% | Experimental | Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.2%Ophthalmic Eyelid wipe |
| IVW-1001 0.4% | Experimental | Drug: IVW-1001 Ophthalmic Eyelid Wipe 0.4%Ophthalmic Eyelid Wipe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported diagnosis of DED in one or both eyes
- BCVA +0.70 logarithm of minimum angle of refraction (Snellen equivalent 20/100) or better in each eye at the Screening Visit
- For women of childbearing potential, confirmed negative pregnancy test at the Screening Visit, not nursing a child, and willing to comply with one of the acceptable methods of birth control described in the protocol
- History (by subject recollection) of artificial tear use within 30 days prior to the Screening Visit
- Unanesthetized Schirmer's test score 5-19 mm inclusive in at least 1 eye (same eye) at the Screening Visit and the Baseline Visit
Key exclusion criteria (3 listed)
- Corneal fluorescein staining score of 4 in either eye in any zone using the National Eye Institute grading system at either the Screening Visit or the Baseline Visit
- IOP ≥23 mmHg in either eye at either the Screening Visit or the Baseline Visit
- History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
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 0.2%Low dose | Drug | IVW-1001 0.2% |
| IVW-1001 Ophthalmic Eyelid Wipe 0.4%High dose | Drug | IVW-1001 0.4% |
Primary outcome
Unanesthetized Schirmer test
Time frame: 7 days
Tear production
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IVW-1001 Ophthalmic Eyelid Wipe 0.2% and IVW-1001 Ophthalmic Eyelid Wipe 0.4% in people with Dry Eye, 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 5 inclusion and 3 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 27 Mar 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Unanesthetized Schirmer test (time frame: 7 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 27 Mar 2026.