A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

September 5, 2017 updated by: Nicox Ophthalmics, Inc.

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.

Study Type

Interventional

Enrollment (Actual)

516

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Ora Clinical Site Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

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
  • be pregnant, nursing, or planning a pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AC-170 0.24%
1 drop in each eye 3 times daily for up to 6 weeks
Drug: AC-170 0.24%
Placebo Comparator: AC-170 Vehicle
1 drop in each eye 3 times daily for up to 6 weeks
Drug: AC-170 Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of AC 170 0.24% 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 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)
Time Frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
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)
Time Frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
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
Time Frame: up to 12 weeks
Adverse events will be measured through study completion
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicox Ophthalmics, Inc.

Collaborators

ORA, Inc.

Investigators

  • Principal Investigator: Eugene Protzko, MD, Sedeinberg Protzko Eye Associates
  • Principal Investigator: Ranjan Malhotra, MD, Ophthalmology Associates
  • Principal Investigator: M. Ali Haider, DO, Haider Eye Care
  • Principal Investigator: Robert Rice, MD, R&R Eye Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 29, 2016

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

Other Study ID Numbers

  • 15-100-0010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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