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

NicOx

Status and phase

Completed

Phase 3

Conditions

Healthy Subjects

Treatments

Drug: AC-170 0.24%

Drug: AC-170 Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT02756624

15-100-0010

Details and patient eligibility

About

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

Full 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.

Enrollment

516 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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