Comparison of Tolerability Between Two Allergy Drops

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Allergan
Information provided by:
Hom, Milton M., OD, FAAO
ClinicalTrials.gov Identifier:
NCT01390961
First received: July 7, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov Identifier: NCT01390961     History of Changes
Other Study ID Numbers: IIT-000256
Study First Received: July 7, 2011
Last Updated: July 7, 2011
Health Authority: United States: Institutional Review Board

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
Maleic acid
Naphazoline
Pheniramine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Respiratory System Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on April 15, 2014