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Comparison 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
Hom, Milton M., OD, FAAO
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 7, 2011
Last Updated
July 7, 2011
Sponsor
Hom, Milton M., OD, FAAO
Collaborators
Allergan
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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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