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Safety and Efficacy Study of a Eye Drop for Eye Allergy

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
alcaftadine
Placebo
Sponsored by
Vistakon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

alcaftadine ophthalmic solution

inactive ophthalmic solution vehicle

Arm Description

active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).

Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).

Outcomes

Primary Outcome Measures

Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.
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.
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation
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.
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation
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.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2009
Last Updated
February 18, 2015
Sponsor
Vistakon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00889330
Brief Title
Safety and Efficacy Study of a Eye Drop for Eye Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vistakon Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
alcaftadine ophthalmic solution
Arm Type
Experimental
Arm Description
active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
Arm Title
inactive ophthalmic solution vehicle
Arm Type
Placebo Comparator
Arm Description
Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
Intervention Type
Drug
Intervention Name(s)
alcaftadine
Intervention Description
0.25% Ophthalmic Solution, one drop in each eye at each of two visits.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle without active, one drop in each eye at each of two visits.
Primary Outcome Measure Information:
Title
Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.
Description
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.
Time Frame
Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge
Title
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation
Description
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.
Time Frame
Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment
Title
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
Description
0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"
Time Frame
Visit 4 (Day 14) up to 7 minutes following Allergen Challenge
Title
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation
Description
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.
Time Frame
Visit 4 (Day 14) At 20 minutes following Allergen Challenge
Other Pre-specified Outcome Measures:
Title
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14
Description
The number of eyes with any change in visual acuity measurements compared to Day -21.
Time Frame
Visit 2 (Day -14) pre-allergen challenge
Title
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
Description
The number of eyes with any change in visual acuity measurements compared to Day -21
Time Frame
Visit 3 (Day 0) pre-dose, pre-allergen challenge
Title
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
Description
The number of eyes with any change in visual acuity measurements compared to Day -21
Time Frame
Visit 4 (Day 14) pre-dose, pre-allergen challenge
Title
Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14
Description
The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve
Time Frame
Visit 4 (Day 14) pre-dose, pre-allergen challenge
Title
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14
Description
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time Frame
Visit 2 (Day -14) pre-allergen challenge
Title
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
Description
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time Frame
Visit 3 (Day 0) pre-dose, pre-allergen challenge
Title
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge
Description
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time Frame
Visit 3 (Day 0) post-dose, pre-allergen challenge
Title
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
Description
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time Frame
Visit 4 (Day 14) pre-dose, pre-allergen challenge
Title
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge
Description
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time Frame
Visit 4 (Day 14) post-dose, pre-allergen challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Fairfield
State/Province
Ohio
Country
United States
City
Mason
State/Province
Ohio
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21250860
Citation
Torkildsen G, Shedden A. The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis. Curr Med Res Opin. 2011 Mar;27(3):623-31. doi: 10.1185/03007995.2010.548797. Epub 2011 Jan 21.
Results Reference
derived

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Safety and Efficacy Study of a Eye Drop for Eye Allergy

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