A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Derek N. Cunningham, Cunningham, Derek N., O.D., P.A.
ClinicalTrials.gov Identifier:
NCT01339507
First received: April 19, 2011
Last updated: January 26, 2016
Last verified: January 2016
  Purpose
The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after instillation.

Condition
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 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)
Groups/Cohorts
Bepreve
Subjects with a history of allergic conjunctivitis.
Lastacaft
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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 
Study First Received: April 19, 2011
Last Updated: January 26, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2016