A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft

Cunningham, Derek N., O.D., P.A.

Status: Completed

Conditions: Allergic Conjunctivitis

Study type: Observational

Funder types: Industry

Identifiers

NCT01339507

MAC-05-11

Details and patient eligibility

About

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

Full description

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

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

25 participants in 2 patient groups

Bepreve

Description:

Subjects with a history of allergic conjunctivitis.

Lastacaft

Description:

Subjects with a history of allergic conjunctivitis.