Hyperemia
Conditions
Keywords
Ocular redness
Brief summary
To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.
Interventions
Ophthalmic solution to be applied as directed.
DRUGVehicle
Ophthalmic solution to be applied as directed.
For use as needed during the study for evaluating corneal damage.
For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.
Sponsors
ORA, Inc.
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity; * Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
Exclusion criteria
* Have any ocular/systemic health problems * Use of any disallowed medications during the period indicated prior to Baseline (Visit 1) and for the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline up to Day 29 | TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drop Comfort Assessment as Assessed by the Participant | At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1 | Drop comfort assessment (0-10 unit scale in which a score of 0 denotes very comfortable and 10 is very uncomfortable) was performed by the participant. Participant's average score across eyes at each time point were used for analysis. |
| Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29 | An alertness evaluation was performed by the Investigator asking the participant and/or participant's parent/legal guardian (pediatric participants only) a few questions based on the previous week. Using those answers, along with his/her clinical opinion, the Investigator made an assessment of the participant's level of alertness using the following 6-point scale: fully alert, alert, lethargy, obtunded, stupor, or coma. |
Countries
United States
Participant flow
Pre-assignment details
Participants were randomized in a 2:1 ratio to receive brimonidine tartrate ophthalmic solution or the vehicle of brimonidine tartrate ophthalmic solution, respectively.
Participants by arm
| Arm | Count |
|---|---|
| Brimonidine Tartrate Participants applied 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. | 337 |
| Brimonidine Tartrate Vehicle Participants applied 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks. | 170 |
| Total | 507 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative reasons | 2 | 1 |
| Overall Study | Adverse Event | 5 | 2 |
| Overall Study | Investigator Decision | 3 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Brimonidine Tartrate | Brimonidine Tartrate Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 17.13 | 41.0 years STANDARD_DEVIATION 17.68 | 40.8 years STANDARD_DEVIATION 17.3 |
| Sex: Female, Male Female | 200 Participants | 100 Participants | 300 Participants |
| Sex: Female, Male Male | 137 Participants | 70 Participants | 207 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 337 | 14 / 170 |
| serious Total, serious adverse events | 2 / 337 | 0 / 170 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline up to Day 29
Population: All randomized participants who received at least 1 dose of study drug (Safety Population).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brimonidine Tartrate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants with at Least 1 Ocular TEAE | 44 Participants |
| Brimonidine Tartrate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants with at least 1 Serious TEAE | 2 Participants |
| Brimonidine Tartrate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants with at least 1 Non-Ocular TEAE | 23 Participants |
| Brimonidine Tartrate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants Discontinued from Study due to TEAEs | 5 Participants |
| Brimonidine Tartrate | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants with at Least 1 TEAE | 66 Participants |
| Brimonidine Tartrate Vehicle | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants Discontinued from Study due to TEAEs | 2 Participants |
| Brimonidine Tartrate Vehicle | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants with at Least 1 TEAE | 38 Participants |
| Brimonidine Tartrate Vehicle | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants with at Least 1 Ocular TEAE | 25 Participants |
| Brimonidine Tartrate Vehicle | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants with at least 1 Non-Ocular TEAE | 16 Participants |
| Brimonidine Tartrate Vehicle | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Participants with at least 1 Serious TEAE | 0 Participants |
Secondary
Drop Comfort Assessment as Assessed by the Participant
Drop comfort assessment (0-10 unit scale in which a score of 0 denotes very comfortable and 10 is very uncomfortable) was performed by the participant. Participant's average score across eyes at each time point were used for analysis.
Time frame: At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1
Population: All randomized participants who received at least 1 dose of study drug (Safety Population).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Tartrate | Drop Comfort Assessment as Assessed by the Participant | Upon Dose Installation | 0.4 units on a scale | Standard Deviation 0.9 |
| Brimonidine Tartrate | Drop Comfort Assessment as Assessed by the Participant | 30 Seconds Postdose Installation | 0.4 units on a scale | Standard Deviation 0.9 |
| Brimonidine Tartrate | Drop Comfort Assessment as Assessed by the Participant | 1 Minute Postdose Installation | 0.4 units on a scale | Standard Deviation 0.83 |
| Brimonidine Tartrate Vehicle | Drop Comfort Assessment as Assessed by the Participant | Upon Dose Installation | 0.4 units on a scale | Standard Deviation 0.77 |
| Brimonidine Tartrate Vehicle | Drop Comfort Assessment as Assessed by the Participant | 30 Seconds Postdose Installation | 0.3 units on a scale | Standard Deviation 0.85 |
| Brimonidine Tartrate Vehicle | Drop Comfort Assessment as Assessed by the Participant | 1 Minute Postdose Installation | 0.4 units on a scale | Standard Deviation 0.83 |
Secondary
Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29
An alertness evaluation was performed by the Investigator asking the participant and/or participant's parent/legal guardian (pediatric participants only) a few questions based on the previous week. Using those answers, along with his/her clinical opinion, the Investigator made an assessment of the participant's level of alertness using the following 6-point scale: fully alert, alert, lethargy, obtunded, stupor, or coma.
Time frame: Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29
Population: All randomized participants who received at least 1 dose of study drug (Safety Population) with evaluable alertness data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brimonidine Tartrate | Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Postdose Installation on Day 1 | 336 Participants |
| Brimonidine Tartrate | Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Postdose Installation on Day 15 | 326 Participants |
| Brimonidine Tartrate | Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Postdose Installation on Day 8 | 326 Participants |
| Brimonidine Tartrate | Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Postdose Installation on Day 29 | 323 Participants |
| Brimonidine Tartrate | Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Predose Installation on Day 1 | 337 Participants |
| Brimonidine Tartrate Vehicle | Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Postdose Installation on Day 29 | 164 Participants |
| Brimonidine Tartrate Vehicle | Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Predose Installation on Day 1 | 170 Participants |
| Brimonidine Tartrate Vehicle | Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Postdose Installation on Day 1 | 169 Participants |
| Brimonidine Tartrate Vehicle | Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Postdose Installation on Day 8 | 167 Participants |
| Brimonidine Tartrate Vehicle | Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29 | Postdose Installation on Day 15 | 166 Participants |