NCT02756624

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 26, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

April 20, 2016

Results QC Date

June 27, 2017

Last Update Submit

September 5, 2017

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

  • Tolerability of AC 170 0.24% at Visit 1 (Day 1)

    Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes 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% at Visit 2 (Day 8)

    Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes 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% at Visit 3 (Day 22)

    Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes 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

  • Number of Treatment Related Adverse Events

    Adverse events will be measured through study completion

    up to 12 weeks

Study Arms (2)

AC-170 0.24%

EXPERIMENTAL

1 drop in each eye 3 times daily for up to 6 weeks

Drug: AC-170 0.24%

AC-170 Vehicle

PLACEBO COMPARATOR

1 drop in each eye 3 times daily for up to 6 weeks

Drug: AC-170 Vehicle

Interventions

AC-170 0.24%DRUG
AC-170 0.24%
AC-170 VehicleDRUG
AC-170 Vehicle

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ora Clinical Site Network

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Interventions

Cetirizine

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President
Organization
Nicox Ophthalmics Inc.
bergamini@nicox.com
817-529-9315

Study Officials

  • Eugene Protzko, MD

    Sedeinberg Protzko Eye Associates

    PRINCIPAL INVESTIGATOR

  • Ranjan Malhotra, MD

    Ophthalmology Associates

    PRINCIPAL INVESTIGATOR

  • Stacey Ackerman, MD

    Philadelphia Eye Associates

    PRINCIPAL INVESTIGATOR

  • M. Ali Haider, DO

    Haider Eye Care

    PRINCIPAL INVESTIGATOR

  • Robert Rice, MD

    R&R Eye Research

    PRINCIPAL INVESTIGATOR

  • Gail Torkildsen, MD

    Andover Eye Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 29, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 11, 2017

Results First Posted

July 26, 2017

Record last verified: 2017-09

Locations

US(1)