Completed

NCT Number: NCT02132169

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

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).

Completed

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Key information

Conditions

Atopic Disease (Including Allergic Conjunctivitis)

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ora, Inc.

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug: AC-170 0.24%

Drug

Other names: 1 drop in each eye 2 times daily for up to 6 weeks

AC-170 0%

Drug

Other names: 1 drop in each eye 2 times daily for up to 6 weeks

Primary outcomes

Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)

Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

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.
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8)

Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

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.
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22)

Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

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.

Secondary outcomes

Safety of AC 170 0.024% Compared to Its Vehicle

Time frame: Up to 12 Weeks

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).

Sponsors and collaborators

Lead sponsor

Aciex Therapeutics, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: May 7, 2014
Registry last updated: Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.