- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01390961
Comparison of Tolerability Between Two Allergy Drops
July 7, 2011 updated by: Hom, Milton M., OD, FAAO
Comfort is compared between two allergy drops
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Azusa, California, United States, 91702
- Milton M. Hom, OD, FAAO.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability
Time Frame: 8 weeks
|
Tolerability measured by questionnaire Visual Analog scale 1 to 100
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
January 1, 2012
Study Registration Dates
First Submitted
July 7, 2011
First Submitted That Met QC Criteria
July 7, 2011
First Posted (Estimate)
July 11, 2011
Study Record Updates
Last Update Posted (Estimate)
July 11, 2011
Last Update Submitted That Met QC Criteria
July 7, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Hypersensitivity
- Conjunctival Diseases
- Conjunctivitis
- Conjunctivitis, Allergic
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Dermatologic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Vasoconstrictor Agents
- Nasal Decongestants
- Pheniramine
- Naphazoline
Other Study ID Numbers
- IIT-000256
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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