Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

Study Overview
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Brief Summary
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Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease

Detailed Description
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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.

Official Title
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A Phase 1/2a, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Exploratory Activity of Two Concentrations of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: ALY688 0.1%
* Drug: ALY688 0.4%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dry eye disease for > 3 months meeting specific sign and symptom criteria Best correct visual acuity of +0.6 logMAR or better Willing to sign informed consent and attend study visits Willing to comply with contraception requirements Exclusion Criteria: Unable to meet specific sign and symptom criteria Signs of ophthalmic allergic, inflammatory or infectious conditions Use of contact lenses Anatomic abnormalities preventing accurate study assessments Use of medications that influence eye dryness Recent ophthalmic surgery Unwilling to suspend current treatments for dry eye disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Vehicle Ophthalmic Solution | Drug: Vehicle<br>* Vehicle Ophthalmic Solution<br>* Other names: placebo;|
| Experimental: ALY688 0.1%<br>ALY688 0.1% Ophthalmic Solution | Drug: ALY688 0.1%<br>* ALY688 0.1% Ophthalmic Solution<br>* Other names: ALY688 Ophthalmic;|
| Experimental: ALY688 0.4%<br>ALY688 0.4%Ophthalmic Solution | Drug: ALY688 0.4%<br>* ALY688 0.4% Ophthalmic Solution<br>* Other names: ALY688 Ophthalmic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |