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
Recruitment status was Recruiting
Sponsor:
Cunningham, Derek N., O.D., P.A.
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Cunningham, Derek N., O.D., P.A.
ClinicalTrials.gov Identifier:
NCT01339507
First received: April 19, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
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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.:
| Estimated Enrollment: | 25 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | September 2011 |
| 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:
- Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis.
- Have allergic ocular symptoms within the last three days.
- Are willing/able to follow instructions from the study investigator and his/her staff.
- 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:
- 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.).
- 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.
- Are pregnant or nursing/lactating.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339507
Contacts
| Contact: Derek Cunningham, OD | 512.347.0255 | dcunningham@dellvision.com |
Locations
| 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
Investigators
| 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 Conjunctivitis, Allergic Conjunctival Diseases Eye Diseases |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013