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Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease
This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Vehicle Ophthalmic Solution |
|
| ALY688 0.1% | Experimental | ALY688 0.1% Ophthalmic Solution |
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| ALY688 0.4% | Experimental | ALY688 0.4%Ophthalmic Solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALY688 0.1% | Drug | ALY688 0.1% Ophthalmic Solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events | Subjects reporting any treatment-emergent adverse events | 8 weeks |
| Eye Dryness Score (7-Day Average) | Mean change from baseline in eye dryness score (7-day average) using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse | 8 weeks |
| Corneal Fluorescein Staining | Mean change from baseline in zonal corneal fluorescein staining score in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Discomfort Score by Visual Analog Scale | Mean change from baseline in ocular discomfort score of 7-day average using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse | 8 weeks |
| Symptom Assessment in Dry Eye (SAnDE) Score Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Hsu, MD | Allysta Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allysta Pharmaceuticals | Bellevue | Washington | 98006 | United States |
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8 investigational sites in the United States
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle Ophthalmic Solution | Vehicle Ophthalmic Solution (control arm) |
| FG001 | ALY688 Ophthalmic Solution 0.1% | ALY688 Ophthalmic Solution Concentration 1 |
| FG002 | ALY688 Ophthalmic Solution 0.4% | ALY688 Ophthalmic Solution Concentration 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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mITT Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle Ophthalmic Solution | Vehicle Ophthalmic Solution (control) |
| BG001 | ALY688 Ophthalmic Solution 0.1% | ALY688 Ophthalmic Solution Concentration 1 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Subjects With Adverse Events | Subjects reporting any treatment-emergent adverse events | Safety Population | Posted | Count of Participants | Participants | 8 weeks |
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Duration of study (8 weeks)
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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 | Vehicle Ophthalmic Solution | Vehicle Ophthalmic Solution (control arm) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vascular pseudoaneurysm | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Admin | Allysta Pharmaceuticals, Inc. | (510) 560-6592 | clinicaltrial.admin@allysta.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2020 | Apr 18, 2023 | Prot_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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| ALY688 0.4% | Drug | ALY688 0.4% Ophthalmic Solution |
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| Vehicle | Drug | Vehicle Ophthalmic Solution |
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Mean change from baseline in Symptom Assessment in Dry Eye global symptom score on a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse. Global symptom score is calculated as the square root of the frequency score time the severity score per visit |
| 8 weeks |
| Conjunctival Lissamine Green Staining | Mean change from baseline in zonal conjunctival lissamine green staining in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse | 8 weeks |
| Conjunctival Hyperemia Grading | Mean change from baseline in zonal conjunctival hyperemia in study eye using a 0- to 4-unit clinical grading scale and standardized grading photos, with 0 being better and 4 being worse | 8 weeks |
| Tear Film Break-up Time (TBUT) | Mean change from baseline in TBUT in study eye | 8 weeks |
| Schirmer's Test | Mean change from baseline in tear volume in study eye as assessed by unanesthetized Schirmer test | 8 weeks |
| BG002 | ALY688 Ophthalmic Solution 0.4% | ALY688 Ophthalmic Solution Concentration 2 |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Eye Dryness Score | Eye Dryness Score using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse | Mean | Standard Deviation | units on a scale |
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ALY688 Ophthalmic Solution Concentration 2
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| Primary | Eye Dryness Score (7-Day Average) | Mean change from baseline in eye dryness score (7-day average) using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse | mITT Population | Posted | Least Squares Mean | Standard Error | units on a scale | 8 weeks |
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| Primary | Corneal Fluorescein Staining | Mean change from baseline in zonal corneal fluorescein staining score in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse | mITT Population | Posted | Least Squares Mean | Standard Error | units on a scale | 8 weeks |
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| Secondary | Ocular Discomfort Score by Visual Analog Scale | Mean change from baseline in ocular discomfort score of 7-day average using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse | Modified Intent-to-Treat (mITT) Population | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Symptom Assessment in Dry Eye (SAnDE) Score Assessment | Mean change from baseline in Symptom Assessment in Dry Eye global symptom score on a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse. Global symptom score is calculated as the square root of the frequency score time the severity score per visit | mITT Population | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Conjunctival Lissamine Green Staining | Mean change from baseline in zonal conjunctival lissamine green staining in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse | mITT Population | Posted | Least Squares Mean | Standard Error | units on a scale | 8 weeks |
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| Secondary | Conjunctival Hyperemia Grading | Mean change from baseline in zonal conjunctival hyperemia in study eye using a 0- to 4-unit clinical grading scale and standardized grading photos, with 0 being better and 4 being worse | mITT Population | Posted | Least Squares Mean | Standard Error | units on a scale | 8 weeks |
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| Secondary | Tear Film Break-up Time (TBUT) | Mean change from baseline in TBUT in study eye | Posted | Least Squares Mean | Standard Error | seconds | 8 weeks |
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| Secondary | Schirmer's Test | Mean change from baseline in tear volume in study eye as assessed by unanesthetized Schirmer test | PP Population | Posted | Least Squares Mean | Standard Error | mm | 8 weeks |
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| 46 |
| 0 |
| 46 |
| 9 |
| 46 |
| EG001 | ALY688 Ophthalmic Solution 0.1% | ALY688 Ophthalmic Solution Concentration 1 | 0 | 46 | 1 | 46 | 6 | 46 |
| EG002 | ALY688 Ophthalmic Solution 0.4% | ALY688 Ophthalmic Solution Concentration 2 | 0 | 46 | 0 | 46 | 6 | 46 |
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| Zone 3 |
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| Zone 4 |
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| Zone 5 |
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| Zone 3 |
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| Zone 4 |
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| Zone 5 |
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| Zone 6 |
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| Temporal |
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