CompletedNCT02039765Updated Apr 28, 2017

Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.

A Phase 1 interventional study of Brimonidine tartrate in Hyperemia, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-28.

Sponsored by Bausch & Lomb Incorporated · Phase 1, Interventional, and Screening

Phase: Phase 1
Study type: Interventional
Enrollment: 12
Allocation: Not applicable
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Hyperemia

Browse trials for

Hyperemia 85

Keywords

Ocular Redness

In context

Hyperemia

85 studies on the registry are indexed under Hyperemia; 37 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 43 interventional studies indexed under Hyperemia.

Browse Hyperemia studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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;
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.

Study design

Phase: Phase 1
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

Experimental
Brimonidine tartrate
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).
Drug: Brimonidine tartrate

Interventions

DrugBrimonidine tartrate

What researchers measure

Primary outcomes

Plasma Levels
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 8 (Visit 5)

Secondary outcomes

Visual Acuity
Visual acuity testing should be done with best correction at 10ft
Time frame: 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.
Time frame: Baseline (Visit 1)
Intraocular Pressure
Intraocular Pressure measured at baseline Day 8 (Visit 5)
Time frame: Day 8 (Visit 5)
Hematology and Blood Chemistry Analysis
Blood samples will be collected for hematology and blood chemistry parameters at Baseline (Visit 1)
Time frame: Baseline (Visit 1)
Urinalysis
Urine sample will be collected for urinalysis at Baseline (Visit 1)
Time frame: Baseline (Visit 1)
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
Time frame: Day 1 (Visit 2)
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
Time frame: Day 7 (Visit 4)
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 8 (Visit 5)
Intraocular Pressure
Intraocular Pressure measured at baseline (Visit 1)
Time frame: Baseline (Visit 1)
Hematology and Blood Chemistry Analysis
Blood samples will be collected for hematology and blood chemistry parameters at Day 8 (Visit 5)
Time frame: Day 8 (Visit 5)
Urinalysis
Urine sample will be collected for urinalysis at Day 8 (Visit 5)
Time frame: Day 8 (Visit 5)

Study locations

1 site

Bausch & Lomb, Incorporated
Rochester, New York 14609, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02039765
Lead sponsor: Bausch & Lomb Incorporated
Collaborators: ORA, Inc.
Responsible party: Sponsor
First posted: Jan 20, 2014
Start date: Feb 2014
Primary completion: Mar 2014
Completion: Apr 2014
Last update: Apr 28, 2017

Study contacts

Joseph Ciolino, MD

study director · ORA, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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