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)

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 Overview

• Status: Completed
• Conditions: Atopic Disease (Including Allergic Conjunctivitis)
• Intervention / Treatment: Drug: Drug: AC-170 0.24%; Drug: AC-170 0%

• Study Type: Interventional
• Enrollment (Actual): 512
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • ORA, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AC-170 0.24%	Drug: Drug: AC-170 0.24%; Other Names: 1 drop in each eye 2 times daily for up to 6 weeks
PLACEBO_COMPARATOR: AC-170 0%	Drug: AC-170 0%; Other Names: 1 drop in each eye 2 times daily for up to 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 12 Weeks

Collaborators and Investigators

• Sponsor: Aciex Therapeutics, Inc.
• Investigators: Principal Investigator: Stacey L Ackerman, MD, Philadelphia Eye Associates; Principal Investigator: Dawn K De Castro, MD, Andover Eye Associates; Principal Investigator: Edward J Meier, MD, Apex Eye; Principal Investigator: Eugene E Protzko, MD, Seidenberg Protzko Eye Associates

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (ESTIMATE): May 7, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Cetirizine
• Other Study ID Numbers: 14-100-0006