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A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft

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ClinicalTrials.gov Identifier: NCT01339507
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : January 27, 2016
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Derek N. Cunningham, Cunningham, Derek N., O.D., P.A.

Brief Summary:
The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after instillation.

Condition or disease
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.

Study Type : Observational
Actual Enrollment : 25 participants
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
Study Start Date : April 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
Drug Information available for: Alcaftadine

Group/Cohort
Bepreve
Subjects with a history of allergic conjunctivitis.
Lastacaft
Subjects with a history of allergic conjunctivitis.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Criteria

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.

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): NCT01339507


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

Responsible Party: Derek N. Cunningham, PI, Cunningham, Derek N., O.D., P.A.
ClinicalTrials.gov Identifier: NCT01339507     History of Changes
Other Study ID Numbers: MAC-05-11
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Alcaftadine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs