A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects with dry eye syndrome.

Official Title
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A Single-Center, Phase 2a, Randomized, Double Masked, Clinical Study to Assess the Safety, Tolerability, and Pharmacodynamic Activity of ADX-102 Ophthalmic Solution in Subjects With Dry Eye Syndrome

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: ADX-102 Ophthalmic Solution (0.5%)
* Drug: ADX-102 Ophthalmic Solution (0.1%)
* Drug: ADX-102 Ophthalmic Lipid Solution (0.5%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age of either gender and any race; Have a reported history of dry eye for at least 6 months prior to Visit 1; Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1; Exclusion Criteria: Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 45 days of Visit 1; Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within the last 6 months; Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX-102 Ophthalmic Solution (0.5%)<br> | Drug: ADX-102 Ophthalmic Solution (0.5%)<br>* ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.<br>|
| Experimental: ADX-102 Ophthalmic Solution (0.1%)<br> | Drug: ADX-102 Ophthalmic Solution (0.1%)<br>* ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.<br>|
| Experimental: ADX-102 Ophthalmic Lipid Solution (0.5%)<br> | Drug: ADX-102 Ophthalmic Lipid Solution (0.5%)<br>* ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety and tolerability of ADX-102 formulations using adverse event query. | Evaluate the safety and tolerability of ADX-102 formulations in subjects with dry eye syndrome. | Safety Assessment Period (Day 1 through Day 29) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of ADX-102 on ocular discomfort using the Ora Calibra® Ocular Discomfort scale. | Evaluate the symptoms of ADX-102 on ocular discomfort in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 29) | 
| Efficacy of ADX-102 on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale. | Evaluate the dry eye symptoms of ADX-102 in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 29) | 
| Efficacy of ADX-102 on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) © questionnaire. | Evaluate the symptoms of ADX-102 in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 29) | 
| Efficacy of ADX-102 on tear film break-up time (TFBUT©). | Evaluate tear film break-up time of ADX-102 in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 29) | 
| Efficacy of ADX-102 on fluorescein staining using the Ora Calibra® scale. | Evaluate fluorescein staining of ADX-102 in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 29) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aldeyra