Skip to main content
OpenTrials
Completed

NCT Number: NCT02756624

A Multi-Center, 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ora Clinical Site Network

Andover, Massachusetts, 01810, United States

About this study

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.

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
  • be pregnant, nursing, or planning a pregnancy

Treatment and study plan

AC-170 0.24%

Drug

AC-170 Vehicle

Drug

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Number of Treatment Related Adverse Events

    Time frame: up to 12 weeks

    Adverse events will be measured through study completion

Sponsors and collaborators

Lead sponsor

Nicox Ophthalmics, Inc.

Industry

Collaborators

  • ORA, Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2016
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.