A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

Study Overview
=================
Brief Summary
-----------------
This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution

Detailed Description
-----------------
Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.

Official Title
-----------------
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

Conditions
-----------------
Healthy Subjects

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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 be pregnant, nursing, or planning a pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>1 drop in each eye 3 times daily for up to 6 weeks | Drug: AC-170 0.24%<br> <br> |
| Placebo Comparator: AC-170 Vehicle<br>1 drop in each eye 3 times daily for up to 6 weeks | Drug: AC-170 Vehicle<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of AC 170 0.24% at Visit 1 (Day 1) | Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes 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% at Visit 2 (Day 8) | Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes 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% at Visit 3 (Day 22) | Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes 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 | 
| Number of Treatment Related Adverse Events | Adverse events will be measured through study completion | up to 12 weeks |