Allergic ConjunctivitisNCT01339507
A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft
An observational study of Allergic Conjunctivitis, run by Cunningham, Derek N., O.D., P.A. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after instillation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are diagnosed with allergic conjunctivitis and who meet all other inclusion/exclusion criteria will be eligible to enter the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft in Patients With a History of Allergic Conjunctivitis
The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after instillation.
Read the detailed description
After one drop is instilled subjects will complete a comfort assessment at 1, 3, 5, and 10 minutes after drop instillation.
- Conditions
- Allergic Conjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bepreve | Subjects with a history of allergic conjunctivitis. | |
| Lastacaft | Subjects with a history of allergic conjunctivitis. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cunningham, Derek N., O.D., P.A.
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, Derek N. Cunningham, Cunningham, Derek N., O.D., P.A.
- Investigators
- Derek Cunningham, OD, Principal investigator, Dell Laser Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339507
- Sponsor's protocol ID
- MAC-05-11
- Status last verified
- Jan 2016
- First submitted
- 19 Apr 2011
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft in Patients With a History of Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT01339507
- Acronym / sponsor ID
- MAC-05-11
- Conditions
- Allergic Conjunctivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cunningham, Derek N., O.D., P.A.
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Apr 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after instillation.
Detailed description
After one drop is instilled subjects will complete a comfort assessment at 1, 3, 5, and 10 minutes after drop instillation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bepreve | – | –Subjects with a history of allergic conjunctivitis. |
| Lastacaft | – | –Subjects with a history of allergic conjunctivitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with allergic conjunctivitis and who meet all other inclusion/exclusion criteria will be eligible to enter the study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Cunningham, OD principal investigator
Dell Laser Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Conjunctivitis, run by Cunningham, Derek N., O.D., P.A. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.