Phase 3 N=516 Randomized Triple-blind Treatment

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

Healthy Subjects

Bottom Line

View on ClinicalTrials.gov: NCT02756624 ↗

Enrolled (actual)

516

Serious AEs

0.4%

Results posted

Jul 2017

Primary outcome: Primary: Tolerability of AC 170 0.24% at Visit 1 (Day 1) — 0.87; 0.50; 0.64; 0.42 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: AC-170 0.24% (Drug); AC-170 Vehicle (Drug)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: Nicox Ophthalmics, Inc.
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Tolerability of AC 170 0.24% at Visit 1 (Day 1)	0.87; 0.50; 0.64; 0.42; 0.42; 0.31	—
PRIMARY Tolerability of AC 170 0.24% at Visit 2 (Day 8)	0.65; 0.19; 0.38; 0.24; 0.26; 0.21	—
PRIMARY Tolerability of AC 170 0.24% at Visit 3 (Day 22)	0.66; 0.43; 0.37; 0.25; 0.24; 0.14	—
PRIMARY Number of Treatment Related Adverse Events	27; 15	—

Summary

This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02756624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.