A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Cunningham, Derek N., O.D., P.A..
Recruitment status was  Recruiting
Bausch & Lomb Incorporated
Information provided by:
Cunningham, Derek N., O.D., P.A.
ClinicalTrials.gov Identifier:
First received: April 19, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
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 Cunningham, Derek N., O.D., P.A.:

Estimated Enrollment: 25
Study Start Date: April 2011
Estimated Study Completion Date: September 2011
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
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.

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

Contact: Derek Cunningham, OD 512.347.0255 dcunningham@dellvision.com

United States, Texas
Derek Cunningham Recruiting
901 S. Mopac Expy, Bldg. 4, Suite 350, Texas, United States, 78746
Contact: Derek Cunningham, OD    512.347.0255    dcunningham@dellvision.com   
Sponsors and Collaborators
Cunningham, Derek N., O.D., P.A.
Bausch & Lomb Incorporated
Principal Investigator: Derek Cunningham, OD Dell Laser Consultants
  More Information

No publications provided

Responsible Party: Derek Cunningham, Dell Laser Consultants
ClinicalTrials.gov Identifier: NCT01339507     History of Changes
Other Study ID Numbers: MAC-05-11
Study First Received: April 19, 2011
Last Updated: April 19, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2015