Comparison of Tolerability Between Two Allergy Drops

This study is enrolling participants by invitation only.
Information provided by:
Hom, Milton M., OD, FAAO Identifier:
First received: July 7, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted

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

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01390961

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

No publications provided

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice 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, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Maleic acid
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
Dermatologic Agents processed this record on April 15, 2014