A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis
Primary Purpose
Conjunctivitis, Allergic
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olopatadine
Fluticasone
Saline
Artificial tears
Sponsored by
About this trial
This is an interventional treatment trial for Conjunctivitis, Allergic focused on measuring Allergic conjunctivitis, Allergic rhinoconjunctivitis
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age & either sex, any race
- Willing and able to follow all instructions and attend all study visits
- Positive history of ocular allergies
- Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge
Exclusion Criteria:
- Have planned surgery during trial period
- Female currently pregnant, planning a pregnancy, or lactating
- Use of disallowed medications
Sites / Locations
- Ophthalmic Research Associates, Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Olopatadine
Fluticasone
Placebo nasal spray
Placebo Eyedrops
Outcomes
Primary Outcome Measures
Ocular itching
Secondary Outcome Measures
Ocular redness
Full Information
NCT ID
NCT00655109
First Posted
April 2, 2008
Last Updated
April 2, 2008
Sponsor
Greiner, Jack V., OD DO PhD
1. Study Identification
Unique Protocol Identification Number
NCT00655109
Brief Title
A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis
Official Title
A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Greiner, Jack V., OD DO PhD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis
Detailed Description
Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Allergic
Keywords
Allergic conjunctivitis, Allergic rhinoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Olopatadine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Fluticasone
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo nasal spray
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo Eyedrops
Intervention Type
Drug
Intervention Name(s)
Olopatadine
Intervention Description
Ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Fluticasone
Intervention Description
Nasal spray
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Nasal spray
Intervention Type
Drug
Intervention Name(s)
Artificial tears
Intervention Description
Ophthalmic Solution
Primary Outcome Measure Information:
Title
Ocular itching
Time Frame
Minutes following CAC
Secondary Outcome Measure Information:
Title
Ocular redness
Time Frame
Minutes following CAC
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age & either sex, any race
Willing and able to follow all instructions and attend all study visits
Positive history of ocular allergies
Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge
Exclusion Criteria:
Have planned surgery during trial period
Female currently pregnant, planning a pregnancy, or lactating
Use of disallowed medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack V Greiner, OD, DO, PhD
Organizational Affiliation
ORA, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Research Associates, Inc
City
North Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis
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