Completed
A Single-Center, Double-Masked, Randomization, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of AC-170 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
What is being tested
AC-170 0.24%
+ AC-170 0%
Drug
Who is being recruted
Conjunctival Diseases+4
+ Conjunctivitis
+ Eye Diseases
Over 10 Years
+4 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: September 2012
Summary
Principal SponsorAciex Therapeutics, Inc.
Last updated: October 10, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.
Principal SponsorAciex Therapeutics, Inc.
Last updated: October 10, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 10 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Conjunctival DiseasesConjunctivitisEye DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesConjunctivitis, Allergic
Criteria
1 inclusion criteria required to participate
positive bilateral conjunctival allergen challenge (CAC)reaction
3 exclusion criteria prevent from participating
any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
known contraindications or sensitivities to the study medication or its components
use of disallowed medication during the period indicated prior to the enrollment or during the study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center