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NCT01959243 · ClinicalTrials.gov registry record · Phase 3
Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 507
- Enrollment target
NCT01959243: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT01959243 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 507 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01959243, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 507 participants
- Enrollment target
Study 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.
Primary Outcome
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 congeni
Interventions
- DRUG Vehicle
- DRUG Brimonidine Tartrate
- DRUG Sodium Fluorescein
- DRUG Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2014-02-22 |
| Est. Completion | 2014-06-23 |
| Phase | Phase 3 |
What the finished NCT01959243 record still lists
NCT01959243 is an interventional study that assigns participants to a tested intervention. The registered 507 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 4 interventions - of which Vehicle is the first listed.
NCT01959243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01959243 about?
NCT01959243 is a clinical study titled "Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants". 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.
What is the current status of trial NCT01959243?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 507 participants. The study started on 2014-02-22. Estimated completion is 2014-06-23.
What interventions are being tested in trial NCT01959243?
The interventions under investigation include: Vehicle (DRUG), Brimonidine Tartrate (DRUG), Sodium Fluorescein (DRUG), Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP (DRUG).
Who is sponsoring clinical trial NCT01959243?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01959243's enrollment target sits among peer trials
507 739th of 2000 higher than 1,260 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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