Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Pediatric, Adult, and Geriatric Subjects

Conditions
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Hyperemia

Intervention / Treatment
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* Drug: Brimonidine Tartrate
* Drug: Vehicle
* Drug: Sodium Fluorescein
* Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brimonidine Tartrate<br>Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. | Drug: Brimonidine Tartrate<br>* Ophthalmic solution to be applied as directed.<br>Drug: Sodium Fluorescein<br>* For use as needed during the study for evaluating corneal damage.<br>Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP<br>* For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.<br>|
| Placebo Comparator: Brimonidine Tartrate Vehicle<br>Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks. | Drug: Vehicle<br>* Ophthalmic solution to be applied as directed.<br>Drug: Sodium Fluorescein<br>* For use as needed during the study for evaluating corneal damage.<br>Drug: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP<br>* For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline up to Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1 | 
| 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. | Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular redness