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Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVW-1001 0.1% | Experimental | IVW-1001 Ophthalmic Eyelid Wipe 0.1% |
|
| IVW-1001 0.2% | Experimental | IVW-1001 Ophthalmic Eyelid Wipe 0.1% |
|
| IVW-1001 Placebo | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVW-1001 Ophthalmic Eyelid Wipe 0.1% | Drug | IVW-1001 Ophthalmic Eyelid Wipe 0.1% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer's | Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness) | 29 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Mean change from baseline in best corrected visual acuity | 29 Days |
| Total Corneal Fluorescein Staining Score in the Study Eye | Change from baseline in score on a scale (0 - none - to 20 - severe) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Liang, PhD | IVIEW Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Eye Associates | Houston | Texas | 77025 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | IVW-1001 0.1% | IVW-1001 Ophthalmic Eyelid Wipe 0.1% IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1% |
| FG001 | IVW-1001 0.2% | IVW-1001 Ophthalmic Eyelid Wipe 0.1% IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2% |
| FG002 | IVW-1001 Placebo | Vehicle IVW-1001 Placebo: IVW-1001 Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IVW-1001 0.1% | IVW-1001 Ophthalmic Eyelid Wipe 0.1% IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1% |
| BG001 | IVW-1001 0.2% | IVW-1001 Ophthalmic Eyelid Wipe 0.1% IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Schirmer's | Mean change from baseline in study eye in unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness) | Posted | Mean | Standard Deviation | mm | 29 Days |
|
Week 4
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVW-1001 0.1% | IVW-1001 Ophthalmic Eyelid Wipe 0.1% IVW-1001 Ophthalmic Eyelid Wipe 0.1%: IVW-1001 Ophthalmic Eyelid Wipe 0.1% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye disorders | Eye disorders | MedDRA version 27.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bo Liang, PhD | iView Therapeutics | 609 773 8580 | info@iviewinc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2024 | Oct 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2024 | Oct 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Double-masked
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Double-masked
| IVW-1001 Ophthalmic Eyelid Wipe 0.2% |
| Drug |
IVW-1001 Ophthalmic Eyelid Wipe 0.2% |
|
| IVW-1001 Placebo | Drug | IVW-1001 Placebo |
|
| 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) | 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) | 4 weeks |
| Symptom Assessment in Dry Eye (SANDE): Global Score | Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe) | 4 weeks |
| BG002 | IVW-1001 Placebo | Vehicle IVW-1001 Placebo: IVW-1001 Placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Unanesthetized Schirmer test (Study Eye) | Unanesthetized measure of tear product using Schirmer strip (measured in mm of wetness) | Mean | Standard Deviation | mm |
|
| Total Corneal Fluorescein Staining Score in the Study Eye (0, none to 20, severe) | 0 (none) to 20 (severe) | Mean | Standard Deviation | Score on a scale |
|
| Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score (0, none, to 100, severe) | 0 (none) to 100 (severe) | Mean | Standard Deviation | Score on a scale |
|
| Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score | 0 (none) to 100 (severe) | Mean | Standard Deviation | Score on a scale |
|
| Symptom Assessment in Dry Eye (SANDE): Global Score | 0 (none) to 100 (severe) | Mean | Standard Deviation | Score on a scale |
|
Vehicle IVW-1001 Placebo: IVW-1001 Placebo |
|
|
| Secondary | Visual Acuity | Mean change from baseline in best corrected visual acuity | Posted | Mean | Standard Deviation | Logarithm of Minimum Angle of Resolution | 29 Days |
|
|
|
| Secondary | Total Corneal Fluorescein Staining Score in the Study Eye | Change from baseline in score on a scale (0 - none - to 20 - severe) | Modified Intent to Treat | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
| Secondary | Symptom Assessment in Dry Eye (SANDE): Frequency of Symptoms Score | Change from Baseline in the SANDE visual analog scale (0 - none to 100 - severe) | modified Intent to Treat | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
| Secondary | Symptom Assessment in Dry Eye (SANDE): Severity of Symptoms Score | Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe) | modified intent-to-treat | Posted | Mean | Standard Deviation | Score on a scale | 4 weeks |
|
|
|
| Secondary | Symptom Assessment in Dry Eye (SANDE): Global Score | Change from baseline in the SANDE visual analog scale (0 - none to 100 - severe) | Modified Intent to treat | Posted | Mean | Standard Deviation | Score on a scale | 4 weeks |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 3 |
| 53 |
| EG001 | IVW-1001 0.2% | IVW-1001 Ophthalmic Eyelid Wipe 0.1% IVW-1001 Ophthalmic Eyelid Wipe 0.2%: IVW-1001 Ophthalmic Eyelid Wipe 0.2% | 0 | 48 | 0 | 48 | 5 | 48 |
| EG002 | IVW-1001 Placebo | Vehicle IVW-1001 Placebo: IVW-1001 Placebo | 0 | 49 | 0 | 49 | 4 | 49 |
Investigators to collaborate with Sponsor on publication.