Back to resultsComparison of Tolerability Between Two Allergy Drops
Primary Purpose
Allergic Conjunctivitis
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
alacaftadine and naphazoline HCl & pheniramine maleate
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 18 and over inclusive.
- Males or females
- Patient is in generally good & stable overall health.
- Patient likely to comply with study guidelines & study visits.
- Informed consent signed.
- History of allergic conjunctivitis
- Current symptoms of allergic conjunctivitis assessed by the investigator
Exclusion Criteria:
- Corneal refractive surgery or contact lens wear within 6 months of this study.
- Current use of Restasis
- Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- Pregnant or lactating women.
- Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
Sites / Locations
- Milton M. Hom, OD, FAAO.
Outcomes
Primary Outcome Measures
Tolerability
Tolerability measured by questionnaire Visual Analog scale 1 to 100
Secondary Outcome Measures
Full Information
NCT ID
NCT01390961
First Posted
July 7, 2011
Last Updated
July 7, 2011
Sponsor
Hom, Milton M., OD, FAAO
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01390961
Brief Title
Comparison of Tolerability Between Two Allergy Drops
Official Title
Comparison of Tolerability Between Two Allergy Drops
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hom, Milton M., OD, FAAO
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comfort is compared between two allergy drops
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Allergic conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
alacaftadine and naphazoline HCl & pheniramine maleate
Other Intervention Name(s)
Lastacaft, Opcon A
Intervention Description
once a day
Primary Outcome Measure Information:
Title
Tolerability
Description
Tolerability measured by questionnaire Visual Analog scale 1 to 100
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18 and over inclusive.
Males or females
Patient is in generally good & stable overall health.
Patient likely to comply with study guidelines & study visits.
Informed consent signed.
History of allergic conjunctivitis
Current symptoms of allergic conjunctivitis assessed by the investigator
Exclusion Criteria:
Corneal refractive surgery or contact lens wear within 6 months of this study.
Current use of Restasis
Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
Pregnant or lactating women.
Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
Facility Information:
Facility Name
Milton M. Hom, OD, FAAO.
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Tolerability Between Two Allergy Drops
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