A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft

Allergic Conjunctivitis Clinical Trial

Official title:

A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft in Patients With a History of Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339507
• Other study ID #: MAC-05-11
• Status: Completed
• Phase: N/A
• First received: April 19, 2011
• Last updated: January 26, 2016
• Start date: April 2011
• Est. completion date: June 2011

Study information

• Verified date: January 2016
• Source: Cunningham, Derek N., O.D., P.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Locations

Country	Name	City	State
United States	Derek Cunningham	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Cunningham, Derek N., O.D., P.A.	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States,