A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft

NCT ID: NCT01339507

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergic Conjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bepreve

Subjects with a history of allergic conjunctivitis.

No interventions assigned to this group

Lastacaft

Subjects with a history of allergic conjunctivitis.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role collaborator

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

INDIV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Derek N. Cunningham

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Derek Cunningham, OD

Role: PRINCIPAL_INVESTIGATOR

Dell Laser Consultants

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Derek Cunningham

Austin, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MAC-05-11

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Comparison of Two Contact Lenses
NCT00700752 COMPLETED NA