HealthyNCT00413751
Effect of Brimonidine Tartrate Ophthalmic Solution 0.15% on Pupil Diameter in Normal Eyes
An observational study of Healthy, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Brimonidine tartrate ophthalmic solution 0.15% (Alphagan P)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult active duty personnel between 18 and 50 years of age with best corrected visual acuity of 20/20 or better.
Who cannot join
- Patients not meeting above stated age criteria
- Females that are pregnant or lactating (non pregnant females of childbearing potential will have pregnancy test prior to participating in study)
- History of serious ocular, neurological, cardiovascular disease
- History of severe systemic disease
- History of arrhythmias or high blood pressure
- Patients currently taking any type of ocular or systemic medications except multivitamins.
- Patients with abnormal pupil shape, Addie's pupil, anisocoria, or abnormal pupil defect.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.
- Conditions
- Healthy
- Being tested
- Brimonidine tartrate ophthalmic solution 0.15% (Alphagan P)
- Keywords
- Large pupils rendering night vision difficulties such as haloes, glare, and monocular diplopia
- Medical subject headings
- Diplopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine tartrate ophthalmic solution 0.15% (Alphagan P)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Time perspective
- Prospective
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- KRAIG S. BOWER, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413751
- Sponsor's protocol ID
- WRAMC WU #03-23004
- Status last verified
- Dec 2006
- First submitted
- 19 Dec 2006
- Last updated
- 20 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brimonidine Tartrate Ophthalmic Solution 0.15% on Pupil Diameter in Normal Eyes
- ClinicalTrials.gov ID
- NCT00413751
- Acronym / sponsor ID
- WRAMC WU #03-23004
- Conditions
- Healthy
- Keywords
- Large pupils rendering night vision difficulties such as haloes, glare, and monocular diplopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- First posted
- 20 Dec 2006 (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 objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult active duty personnel between 18 and 50 years of age with best corrected visual acuity of 20/20 or better.
Key exclusion criteria (7 listed)
- Patients not meeting above stated age criteria
- Females that are pregnant or lactating (non pregnant females of childbearing potential will have pregnancy test prior to participating in study)
- History of serious ocular, neurological, cardiovascular disease
- History of severe systemic disease
- History of arrhythmias or high blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) | Drug | – |
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 20 Dec 2006.
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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.
KRAIG S. BOWER, MD principal investigator
Walter Reed Army Medical Center
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 Healthy, run by Walter Reed Army Medical Center 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 1 inclusion and 7 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 20 Dec 2006. 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 20 Dec 2006.