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.

All randomized participants who received at least 1 dose of study drug (Safety Population).

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.

All randomized participants who received at least 1 dose of study drug (Safety Population).

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.

All randomized participants who received at least 1 dose of study drug (Safety Population) with evaluable alertness data.