HyperemiaPhase 1NCT02039765
Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.
A Phase 1 study testing Brimonidine tartrate in people with Hyperemia, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
To characterize the plasma pharmacokinetics and safety profile of brimonidine following a single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution 0.025% for 7 days in healthy, adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperemia
- What is being tested?
- Brimonidine tartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2014
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- have ocular health within normal limits.
- have blood (hematology, blood chemistry) and urine analysis within normal limits.
- have a body weight within 15% of ideal weight
Who cannot join
- have known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol;
- have any active systemic or ocular disorder other than refractive disorder.
- have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the Investigator's opinion could affect ophthalmic drop absorption.
- have a history of chronic alcohol consumption.
- consume alcohol and/or caffeine or xanthine containing products within 48 hours prior to dosing at Visit 1 or anticipated use during the study.
- have a history of tobacco, nicotine, or nicotine containing product use within the last year prior to Visit 2;
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- have significant weight change (over 10 pounds) within the 60 days prior to Visit 2;
- have blood donation or equivalent blood loss of 450 ml or more, within 60 days prior to Visit 2;
- have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg);
- have intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb, Incorporated
Rochester, New York, 14609
About this study
Official title: A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in Healthy, Adult Subjects.
To characterize the plasma pharmacokinetics and safety profile of brimonidine following a single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution 0.025% for 7 days in healthy, adult subjects.
- Conditions
- Hyperemia
- Being tested
- Brimonidine tartrate
- Keywords
- Ocular Redness
- Medical subject headings
- Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine tartrateDrug
| Study group | Role | What they receive |
|---|---|---|
| Brimonidine tartrate | Experimental | One drop of brimonidine tartrate ophthalmic solution 0.025% in each eye once at Visit 2 (Day 1) then four times daily (QID) approximately 4 hours apart at Visit 3 (Day 2) through day 6, and then once at Visit 4 (Day 7). Receives: Drug: Brimonidine tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Levels
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1.
Measured: Day 1 (Visit 2)
Plasma Levels
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 2.
Measured: Day 2 (Visit 3)
Plasma Levels
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 7.
Measured: Day 7 (Visit 4)
Plasma Levels
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 8.
Measured: Day 8 (Visit 5)
Secondary outcomes (14)
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
Measured: Baseline (Visit 1)
Slit Lamp Biomicroscopy
Lid and lid margin erythema and swelling, conjunctival erythema/hyperemia and chemosis will be graded on a scale of 0 - 4. with 0=normal and 4=marked. Half grade measurements will be accepted for erythema/hyperemia.
Measured: Baseline (Visit 1)
Intraocular Pressure
Intraocular Pressure measured at baseline Day 8 (Visit 5)
Measured: Day 8 (Visit 5)
Hematology and Blood Chemistry Analysis
Blood samples will be collected for hematology and blood chemistry parameters at Baseline (Visit 1)
Measured: Baseline (Visit 1)
Urinalysis
Urine sample will be collected for urinalysis at Baseline (Visit 1)
Measured: Baseline (Visit 1)
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
Measured: Day 1 (Visit 2)
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
Measured: Day 7 (Visit 4)
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
Measured: Day 8 (Visit 5)
Slit Lamp Biomicroscopy
Lid and lid margin erythema and swelling, conjunctival erythema/hyperemia and chemosis will be graded on a scale of 0 - 4. with 0=normal and 4=marked. Half grade measurements will be accepted for erythema/hyperemia.
Measured: Day 1 (Visit 2)
Slit Lamp Biomicroscopy
Lid and lid margin erythema and swelling, conjunctival erythema/hyperemia and chemosis will be graded on a scale of 0 - 4. with 0=normal and 4=marked. Half grade measurements will be accepted for erythema/hyperemia.
Measured: Day 7 (Visit 4)
Slit Lamp Biomicroscopy
Lid and lid margin erythema and swelling, conjunctival erythema/hyperemia and chemosis will be graded on a scale of 0 - 4. with 0=normal and 4=marked. Half grade measurements will be accepted for erythema/hyperemia.
Measured: Day 8 (Visit 5)
Intraocular Pressure
Intraocular Pressure measured at baseline (Visit 1)
Measured: Baseline (Visit 1)
Hematology and Blood Chemistry Analysis
Blood samples will be collected for hematology and blood chemistry parameters at Day 8 (Visit 5)
Measured: Day 8 (Visit 5)
Urinalysis
Urine sample will be collected for urinalysis at Day 8 (Visit 5)
Measured: Day 8 (Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperemiaStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Joseph Ciolino, MD, Study director, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039765
- Sponsor's protocol ID
- 863/13-100-0007
- Status last verified
- Apr 2017
- First submitted
- 16 Jan 2014
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in Healthy, Adult Subjects.
- ClinicalTrials.gov ID
- NCT02039765
- Acronym / sponsor ID
- 863/13-100-0007
- Conditions
- Hyperemia
- Keywords
- Ocular Redness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- Feb 2014 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Jan 2014 (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.
To characterize the plasma pharmacokinetics and safety profile of brimonidine following a single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution 0.025% for 7 days in healthy, adult subjects.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brimonidine tartrate | Experimental | Drug: Brimonidine tartrateOne drop of brimonidine tartrate ophthalmic solution 0.025% in each eye once at Visit 2 (Day 1) then four times daily (QID) approximately 4 hours apart at Visit 3 (Day 2) through day 6, and then once at Visit 4 (Day 7). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- have ocular health within normal limits.
- have blood (hematology, blood chemistry) and urine analysis within normal limits.
- have a body weight within 15% of ideal weight
Key exclusion criteria (10 listed)
- have known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol;
- have any active systemic or ocular disorder other than refractive disorder.
- have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the Investigator's opinion could affect ophthalmic drop absorption.
- have a history of chronic alcohol consumption.
- consume alcohol and/or caffeine or xanthine containing products within 48 hours prior to dosing at Visit 1 or anticipated use during the study.
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 | Drug | Brimonidine tartrate |
Primary outcome
Plasma Levels
Time frame: Day 1 (Visit 2)
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1.
Plasma Levels
Time frame: Day 2 (Visit 3)
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 2.
Plasma Levels
Time frame: Day 7 (Visit 4)
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 7.
Plasma Levels
Time frame: Day 8 (Visit 5)
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 8.
14 secondary outcomes
Visual Acuity
Time frame: Baseline (Visit 1)
Slit Lamp Biomicroscopy
Time frame: Baseline (Visit 1)
Intraocular Pressure
Time frame: Day 8 (Visit 5)
Hematology and Blood Chemistry Analysis
Time frame: Baseline (Visit 1)
Urinalysis
Time frame: Baseline (Visit 1)
Visual Acuity
Time frame: Day 1 (Visit 2)
Visual Acuity
Time frame: Day 7 (Visit 4)
Visual Acuity
Time frame: Day 8 (Visit 5)
Slit Lamp Biomicroscopy
Time frame: Day 1 (Visit 2)
Slit Lamp Biomicroscopy
Time frame: Day 7 (Visit 4)
Slit Lamp Biomicroscopy
Time frame: Day 8 (Visit 5)
Intraocular Pressure
Time frame: Baseline (Visit 1)
Hematology and Blood Chemistry Analysis
Time frame: Day 8 (Visit 5)
Urinalysis
Time frame: Day 8 (Visit 5)
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 28 Apr 2017.
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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.
Joseph Ciolino, MD study director
ORA, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brimonidine tartrate in people with Hyperemia, run by Bausch & Lomb Incorporated 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 3 inclusion and 10 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 28 Apr 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Plasma Levels (time frame: Day 1 (Visit 2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 28 Apr 2017.