A Study of ADX-102 in Subjects With Allergic Conjunctivitis

Study Overview
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Brief Summary
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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis.

Conditions
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Conjunctivitis, Allergic

Intervention / Treatment
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* Drug: ADX-102 Ophthalmic Drops (0.5%)
* Drug: ADX-102 Ophthalmic Drops (0.1%)
* Drug: Vehicle of ADX-102 Ophthalmic Drops


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 positive history of ocular allergies and a positive skin test reaction to a seasonal (grasses, ragweed, and/or trees) or perennial allergen (cat dander, dog dander, dust mites, cockroach) as confirmed by an allergic skin test within the past 24 months have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart Exclusion Criteria: have known contraindications or sensitivities to the use of the investigational product or any of its components have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye) have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (6) months have a known history of retinal detachment, diabetic retinopathy, or active retinal disease have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the study duration and for 14 days prior to the installation of investigational product, or has a positive urine pregnancy test at 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX-102 Ophthalmic Drops (0.5%)<br>ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. | Drug: ADX-102 Ophthalmic Drops (0.5%)<br>* ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.<br>|
| Experimental: ADX-102 Ophthalmic Drops (0.1%)<br>ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. | Drug: ADX-102 Ophthalmic Drops (0.1%)<br>* ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.<br>|
| Placebo Comparator: Vehicle of ADX-102 Ophthalmic Drops<br>Vehicle of ADX-102 Ophthalmic Drops | Drug: Vehicle of ADX-102 Ophthalmic Drops<br>* Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. | Efficacy assessment period (Day 1 through Day 15), Day 15 reported. | 
| Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. | Efficacy assessment period (Day 1 through Day 15), Day 15 reported. | 
| Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. | Efficacy assessment period (Day 1 through Day 15), Day 15 reported. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADX-102, Allergic Conjunctivitis