A Multi-Center Study Evaluating the Safety of AC-170 0.24%

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).

Official Title
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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 0.24% Ophthalmic Solution Used Twice Daily in Healthy Adult Subjects and in Pediatric Subjects With a History or Family History of Atopic Disease (Including Allergic Conjunctivitis)

Conditions
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Atopic Disease (Including Allergic Conjunctivitis)

Intervention / Treatment
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* Drug: Drug: AC-170 0.24%
* Drug: AC-170 0%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 2 years of age be able to self-administer eye drops or have a parent/legal guardian available for this purpose if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis) have ocular health within normal limits Exclusion Criteria: known contraindications or sensitivities to the study medication or its components any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters use of disallowed medication during the period indicated prior to the enrollment or during the study

Ages Eligible for Study
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Minimum Age: 2 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AC-170 0.24%<br> | Drug: Drug: AC-170 0.24%<br> <br> * Other names: 1 drop in each eye 2 times daily for up to 6 weeks;|
| Placebo Comparator: AC-170 0%<br> | Drug: AC-170 0%<br> <br> * Other names: 1 drop in each eye 2 times daily for up to 6 weeks;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) | Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable. | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | 
| Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) | Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable. | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | 
| Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) | Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable. | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of AC 170 0.024% Compared to Its Vehicle | Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients). | Up to 12 Weeks |