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Comparison of Tolerability Between Two Allergy Drops

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ClinicalTrials.gov Identifier: NCT01390961
Recruitment Status : Unknown
Verified July 2011 by Hom, Milton M., OD, FAAO.
Recruitment status was:  Enrolling by invitation
First Posted : July 11, 2011
Last Update Posted : July 11, 2011
Sponsor:
Collaborator:
Allergan
Information provided by:
Hom, Milton M., OD, FAAO

Brief Summary:
Comfort is compared between two allergy drops

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: alacaftadine and naphazoline HCl & pheniramine maleate Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Tolerability Between Two Allergy Drops
Study Start Date : August 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Pinkeye


Intervention Details:
  • Drug: alacaftadine and naphazoline HCl & pheniramine maleate
    once a day
    Other Names:
    • Lastacaft
    • Opcon A


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



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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
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.

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

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov Identifier: NCT01390961     History of Changes
Other Study ID Numbers: IIT-000256
First Posted: July 11, 2011    Key Record Dates
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