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Comparison of Tolerability Between Two Allergy Drops

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Hom, Milton M., OD, FAAO.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01390961
First Posted: July 11, 2011
Last Update Posted: July 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by:
Hom, Milton M., OD, FAAO
  Purpose
Comfort is compared between two allergy drops

Condition Intervention Phase
Allergic Conjunctivitis Drug: alacaftadine and naphazoline HCl & pheniramine maleate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Tolerability Between Two Allergy Drops

Resource links provided by NLM:


Further study details as provided by Hom, Milton M., OD, FAAO:

Primary Outcome Measures:
  • Tolerability [ Time Frame: 8 weeks ]
    Tolerability measured by questionnaire Visual Analog scale 1 to 100


Estimated Enrollment: 48
Study Start Date: August 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: alacaftadine and naphazoline HCl & pheniramine maleate
    once a day
    Other Names:
    • Lastacaft
    • Opcon A
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390961


Locations
United States, California
Milton M. Hom, OD, FAAO.
Azusa, California, United States, 91702
Sponsors and Collaborators
Hom, Milton M., OD, FAAO
Allergan
  More Information

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov Identifier: NCT01390961     History of Changes
Other Study ID Numbers: IIT-000256
First Submitted: July 7, 2011
First Posted: July 11, 2011
Last Update Posted: July 11, 2011
Last Verified: July 2011

Keywords provided by Hom, Milton M., OD, FAAO:
Allergic conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Naphazoline
Pheniramine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents