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

Primary Purpose

Atopic Disease (Including Allergic Conjunctivitis)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Drug: AC-170 0.24%
AC-170 0%
Sponsored by
Aciex Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Disease (Including Allergic Conjunctivitis)

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ora, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AC-170 0.24%

AC-170 0%

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
April 29, 2014
Last Updated
September 5, 2017
Sponsor
Aciex Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02132169
Brief Title
A Multi-Center Study Evaluating the Safety of AC-170 0.24%
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aciex Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Disease (Including Allergic Conjunctivitis)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AC-170 0.24%
Arm Type
Experimental
Arm Title
AC-170 0%
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Drug: AC-170 0.24%
Other Intervention Name(s)
1 drop in each eye 2 times daily for up to 6 weeks
Intervention Type
Drug
Intervention Name(s)
AC-170 0%
Other Intervention Name(s)
1 drop in each eye 2 times daily for up to 6 weeks
Primary Outcome Measure Information:
Title
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)
Description
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.
Time Frame
Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Title
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8)
Description
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.
Time Frame
Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Title
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22)
Description
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.
Time Frame
Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Secondary Outcome Measure Information:
Title
Safety of AC 170 0.024% Compared to Its Vehicle
Description
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).
Time Frame
Up to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey L Ackerman, MD
Organizational Affiliation
Philadelphia Eye Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dawn K De Castro, MD
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward J Meier, MD
Organizational Affiliation
Apex Eye
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugene E Protzko, MD
Organizational Affiliation
Seidenberg Protzko Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ora, Inc.
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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