Safety and Efficacy Study of a Eye Drop for Eye Allergy

February 18, 2015 updated by: Vistakon Pharmaceuticals
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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
    • Ohio
      • Fairfield, Ohio, United States
      • Mason, Ohio, United States

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

10 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 10 years of age
  • positive history of ocular allergies
  • positive skin test reaction to allergens.

Exclusion Criteria:

  • known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components
  • ocular surgical intervention within three (3) months prior to visit 1 or during the study
  • known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma
  • any other significant illness

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: alcaftadine ophthalmic solution
active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
Drug: alcaftadine
0.25% Ophthalmic Solution, one drop in each eye at each of two visits.
PLACEBO_COMPARATOR: inactive ophthalmic solution vehicle
Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
Drug: Placebo
Vehicle without active, one drop in each eye at each of two visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.
Time Frame: Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge
A 0 to 4 scale used, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation.
Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation
Time Frame: Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment
A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
Time Frame: Visit 4 (Day 14) up to 7 minutes following Allergen Challenge
0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"
Visit 4 (Day 14) up to 7 minutes following Allergen Challenge
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation
Time Frame: Visit 4 (Day 14) At 20 minutes following Allergen Challenge
A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Visit 4 (Day 14) At 20 minutes following Allergen Challenge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14
Time Frame: Visit 2 (Day -14) pre-allergen challenge
The number of eyes with any change in visual acuity measurements compared to Day -21.
Visit 2 (Day -14) pre-allergen challenge
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
Time Frame: Visit 3 (Day 0) pre-dose, pre-allergen challenge
The number of eyes with any change in visual acuity measurements compared to Day -21
Visit 3 (Day 0) pre-dose, pre-allergen challenge
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
Time Frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge
The number of eyes with any change in visual acuity measurements compared to Day -21
Visit 4 (Day 14) pre-dose, pre-allergen challenge
Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14
Time Frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge
The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve
Visit 4 (Day 14) pre-dose, pre-allergen challenge
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14
Time Frame: Visit 2 (Day -14) pre-allergen challenge
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Visit 2 (Day -14) pre-allergen challenge
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
Time Frame: Visit 3 (Day 0) pre-dose, pre-allergen challenge
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Visit 3 (Day 0) pre-dose, pre-allergen challenge
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge
Time Frame: Visit 3 (Day 0) post-dose, pre-allergen challenge
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Visit 3 (Day 0) post-dose, pre-allergen challenge
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
Time Frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Visit 4 (Day 14) pre-dose, pre-allergen challenge
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge
Time Frame: Visit 4 (Day 14) post-dose, pre-allergen challenge
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Visit 4 (Day 14) post-dose, pre-allergen challenge

Collaborators and Investigators

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

Sponsor

Vistakon Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2009

Primary Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (ESTIMATE)

April 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-003-05

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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