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A Multi-Center Study Evaluating the Safety of AC-170 0.24% | Clinical Trials | Clareo Health

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

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)

NCT02132169•Aciex Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

2 - No limit years

Sex

ALL

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

Locations (1)

Ora, Inc.

Andover, Massachusetts, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

October 1, 2014

Completion Date

October 1, 2014

Last Updated

September 11, 2017

Enrollment

512

ACTUAL participants

Conditions

Atopic Disease (Including Allergic Conjunctivitis)

Interventions

Drug: AC-170 0.24%

DRUG

AC-170 0%

DRUG