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A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft

This study has been completed.
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Derek N. Cunningham, Cunningham, Derek N., O.D., P.A. Identifier:
First received: April 19, 2011
Last updated: January 26, 2016
Last verified: January 2016
The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after instillation.

Allergic Conjunctivitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft in Patients With a History of Allergic Conjunctivitis

Resource links provided by NLM:

Further study details as provided by Derek N. Cunningham, Cunningham, Derek N., O.D., P.A.:

Enrollment: 25
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Subjects with a history of allergic conjunctivitis.
Subjects with a history of allergic conjunctivitis.

Detailed Description:
After one drop is instilled subjects will complete a comfort assessment at 1, 3, 5, and 10 minutes after drop instillation.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients who are diagnosed with allergic conjunctivitis and who meet all other inclusion/exclusion criteria will be eligible to enter the study.

Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study:

  1. Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis.
  2. Have allergic ocular symptoms within the last three days.
  3. Are willing/able to follow instructions from the study investigator and his/her staff.
  4. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

  1. Have known hypersensitivity to either BEPREVE™ or LASTACAFT® or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
  2. Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment.
  3. Are pregnant or nursing/lactating.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01339507

United States, Texas
Derek Cunningham
Austin, Texas, United States, 78746
Sponsors and Collaborators
Cunningham, Derek N., O.D., P.A.
Bausch & Lomb Incorporated
Principal Investigator: Derek Cunningham, OD Dell Laser Consultants
  More Information

Responsible Party: Derek N. Cunningham, PI, Cunningham, Derek N., O.D., P.A. Identifier: NCT01339507     History of Changes
Other Study ID Numbers: MAC-05-11
Study First Received: April 19, 2011
Last Updated: January 26, 2016

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017