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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
512
Ora, Inc.
Andover, Massachusetts, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
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).
Time frame: Up to 12 Weeks
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